Medical Device Daily Washington Editor

The old saying states that the devil is in the details, but when it comes to responses to inspectional findings as documented on the notorious form 483, the devil is sometimes in the lack of details.

That was one lesson to be learned in the Aug. 28 warning letter to Marlen Manufacturing & Development (Bedford, Ohio), maker of colostomy bags and rods, which the agency cited for eight deviations from the quality systems regulations (QSRs). According to FDA, Marlen's response to the 483 "does not provide any specific detailed corrective action steps" regarding the inspectional findings and did not "provide any supporting documentation." On the other hand, FDA's description of several of the citations listed in the warning letter were short on detail as well.

The warning letter led with a citation for lack of documentation of root causes in each of 35 complaint files reviewed by the FDA investigator. Among the complaints noted were two instances of leaking seals on ileostomy gas relief pouches.

FDA found fault with the firm's validation work on three processes, including a failure to validate the sealing operation on 10 sealing machines used to "manufacture various types of ostomy pouches and valves." Also said to have been unvalidated were the operations of three injection molding machines used to manufacture colostomy rods, and a vacuum mold machine used to manufacture packaging for the firm's products.

Following this citation was one that stated that Marlen had no written procedures for reporting deaths and serious injuries in connection with the firm's devices per Title 21 of the Code of Federal Regulations (CFR), subsection 803.17. This is the portion of CFR that deals with medical device reports, and this citation says nothing more about it, even to the extent that it does not specifically mention MDRs. At the end of the warning letter, however, FDA repeats the finding with the passage that Marlen "failed to develop, implement and maintain written procedures for the reporting of deaths, serious injuries and certain malfunctions as required by 21 CFR 803.17."

FDA states that the company had procedures describing some of the operating parameters for its manufacturing equipment, but cited the firm for failure to document "the machine settings of these variables on the manufacturing equipment." The firm's device history records also came up short in that "five out of five device history records covering all colostomy rods manufactured over the past two years" had no information on the quantity manufactured or released, and did not include a copy of the device label.

As is usually the case, FDA will cite a firm for deviating from its own standard operating procedures, and this inspection led to such a citation. The warning letter cited Marlen for not calibrating twice a year the micrometer used to "determine material acceptance" per procedures.

Two very brief citations in the warning letter were for "failure to conduct management reviews of the quality system" and "failure to inspect or test the plastic films used to manufacture ostomy bags to ensure conformance with your specifications."

This was not the first warning letter FDA issued the company. In a warning letter dated Dec. 26, 1996, the agency cited Marlen for lack of records of quality assurance for finished device inspections and for 13 complaints for which the firm could offer no documentation that it had investigated, a citation that parallels a finding from the current warning letter.

Also suggestive of device-specific record-keeping problems was a citation from 1996 stating that the company's device master records were not signed and dated. FDA also indicated in 1996 that it preferred that Marlen hire an outside consultant to straighten up its compliance program with continuing audits at one-year intervals through June 1998.

At press time, Marlen had not responded to a call for comment.

Medtronic recall elevated to Class I

Medtronic (Minneapolis) announced recently that FDA has elevated its recall of the firm's Sutureless Connector intrathecal catheters to a Class I recall due to the risk of injury or death.

According to the Sept. 14 announcement, the SC catheters are not compatible with some of the firm's IsoMed constant-flow infusion pumps despite labeling indicating otherwise. The affected products include four catheter and revision kit models and the model 8472 IsoMed pump, which Medtronic says it has phased out of production.

Medtronic's statement blamed the incompatibility on an undescribed "physical interference" generated by design differences in the interfaces. This problem could lead to interrupted infusion therapy, hence the risk of injury and/or death. Medtronic reported 10 events of interrupted infusion sessions, with one of the patients passing away. However, the company said, "it cannot be determined whether the cause of death is or is not related to the device."

Pediatric tracheal tubes recalled

Smith Medical (St. Paul, Minnesota) has announced a recall of a number of its line of pediatric tracheal tubes in three sizes due to poor fits that could result in serious medical complications.

According to a Sept. 10 statement posted at the FDA web site, Smith's recall of 17 models from the Portex line of tracheal tubes is due to internal diameters that are "slightly smaller than indicated on the labeling," which may create problems "passing through or withdrawing the suction catheter." The consequent difficulty or impossibility of removing secretions from the patient's airway could create problems with ventilation, hence the class I status of the recall. However, there were no reports of death or permanent injury in connection with the problem as of Sept. 10.

Customers are advised to return the affected product to the company.

Mark McCarty, 703-268-5690;