Medical Device Daily Washington Editor

The July 31 warning letter to Byrne Medical (Conroe, Texas) included substantial detail on seven deviations from the quality systems regulations (QSR), but perhaps the most conspicuous finding was that Byrne had used visual inspection to validate the effects of a corrective action in connection with a water jet connector used in the firm's medical and surgical accessories. Visual inspections have not gone over particularly well with FDA for at least a decade and the warning letter to Byrne is just the latest reminder.

The February-March inspection disclosed a number of problems with corrective and preventive actions (CAPAs), including that Byrne failed to validate a January 2008 rework of water jet connectors until Feb. 16, 2009, the day before the inspection began. The redacted warning letter states further that the company's correction of water jet leakage in an unidentified product "did not include a determination of any adverse effect from the rework."

This four-part citation also noted that the CAPA did not adequately ensure that the test used by Byrne to "accept and release the reworked ... devices can reliably detect fluid leakages at the O-ring" of the reworked connector.

In responding to this finding on the 483, Byrne evidently informed the agency that regulations do not "dictate the extent to which" a CAPA "must be documented and that the details of the problem are documented, and therefore there is no compliance issue."

Needless to say, this assertion was not received well by FDA, which replied in the warning that any such corrections must be fully documented and validated, including to the extent that such a validation will "prove that similar water leaks will not occur in other devices."

This citation was also the source of FDA's remark to the company that visual inspection is not sufficient to validate the results of a CAPA, with the agency noting that the firm's documents failed to explain "why your visual inspection failed to identify and reject all defective water jet connectors."

The warning letter states that Byrne started receiving complaints in December 2007 of a silicone tube that on 15 occasions had either ballooned or bulged and leaked, but the company did not open a CAPA until 12 months later. According to FDA, the CAPA, which was completed this past February, failed to include a trending of the corrected silicone tube "to determine whether or not the quality issue was still recurring."

The company's response was deemed inadequate due largely to lack of information detailing the underlying cause of the distortions in the tubes, but FDA also noted that the revised protocols were not included in the response to the 483.

FDA cited the company for releasing a polyvinyl chloride (PVC) tube set into production "even though it did not meet the flow rate acceptance criteria of [redacted] after sterilization due to the effects of sterilization." The firm's validation documents were said to have lacked data on the type of sterilization and how the sterilization process came to impede the flow rate. FDA asked the firm to provide documentation as to whether the reduced flow rate would have an effect on clinical use of the tubes and states that the firm's response to this finding in the 483 specified neither when corrections would be complete "nor when you will update us on the status" of corrective actions. FDA also queried the firm as to whether the replacement silicone tube might also be affected by the sterilization procedure.

The company and FDA also disagreed on the regulatory status of devices that were the subject of two complaints encompassing 136 units regarding water jet connectors that were "too big ... and cannot screw on scope." This series of complaints also included a reference to "threads [that] appear to be stripping after multiple uses."

Byrne had chalked these events up to a supplier who "incorrectly inspected [the] devices using another manufacturer's specifications," but FDA asserts in the warning that "visual inspections do not cause the threads of the cap nut to be stripped."

The agency also noted that the company's response to this finding on the 483 was that the situation had been corrected, that there was hence "no compliance issue," and that a root cause analysis was unnecessary. Neither of these explanations flew, however, and FDA pointed out that Byrne had not established what had caused the cap nuts "to be improperly drilled."

Byrne apparently received 17 complaints in connection with the EndoGator water jet connector between January and April 2008 for leaks and for failures of the unit to "connect to scope properly," a series of problems apparently attributed to the aforementioned O-rings. FDA states in the warning letter that the company had recalled and replaced the units along with a labeled warning "of potential patient safety risk" in connection with the reworked units. The agency recommended that the company contact FDA's recall coordinator for any such future events.

At press time, Byrne had not responded to calls for comment.

Gaven also cited for visual inspections

Some FDA warning letters are richly detailed, but this is not always the case as the June 26 warning letter to Gaven Medical (Vernon, Connecticut) makes clear. One other thing was also clear from the Gaven warning letter: visual inspections might be popular with small firms, but not with FDA.

The maker of Punctur-Guard wing sets for venous blood collection punctures was cited for device history records that failed to document that Gaven reviewed records in connection with a lot that came back from the contract sterilizer with the note that "the average surface dose received" by the lot in question came in at a dose level that FDA redacted from the warning letter. This was problematic at least in part because Gaven's procedures did not "reference an average surface dose as an appropriate specification." However, the warning letter does not state specifically that this dose was deemed out of specification.

Gaven's contract sterilizer is said to have rejected two other lots earlier in 2008 for reasons not stated in the warning letter, but FDA charged that Gaven "did not have any documentation to demonstrate that these two non-conforming cases" were properly disposed of rather than shipped for use. This situation also led to a citation for failure to conduct a root-cause analysis.

FDA also alleged that Gaven had at least three final specifications for "wing tubing pull tests," and that the company did not have "adequate specifications for peel strength tests" for the product's packaging. "During the inspection, we observed that you stopped conducting burst tests and are only performing a visual inspection of the [package] seals," the warning letter concludes.

The company had not responded to a call and an e-mail for comment by press time.

Mark McCarty, 703-268-5690; mark.mccarty@ahcmedia.com