Rymed Technologies, Franklin, TN, Feb. 9 (Dallas, TX).(MEDICAL DEVICES)

An Oct. 18-Nov. 8 inspection of the manufacturer and marketer of the Invision-Plus Neutral I.V. Connector Models and catheter extension sets found the products were not in conformance with the Quality System regulation.

Some of the violations included but were not limited to the following: failure to establish and maintain procedures for monitoring and control of process parameters for a validated process to ensure that the specified requirements continue to be met; failure to identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems; failure to ensure that information relating quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems; and failure to establish and maintain adequate complaint handling procedures for receiving, reviewing, and evaluating complaints.

The firm did not monitor the validated welding process via an increased sampling plan nor reviewed the test results of the weld integrity of the female luer and the spike body in order to detect changes in the welding process which caused weld failures and the firm's subsequent recall of ten lots of the referenced devices, FDA wrote.

Next, the firm initiated a recall of the referenced devices due to weld failures. However, it failed to ensure that all the affected lots of the referenced devices were effectively retrieved from the market and the users were adequately notified of the firm's recall to prevent further use of the nonconforming devices.

Further, although the firm had a teleconference call with the foreign contract manufacturer and subsequently visited them to discuss the issue of weld failures and initiated additional testing and trouble shooting of your welding machine on April 3, 2006, it failed to maintain documentation of the teleconference call minutes, the letter stated.

In addition, in reviewing six of the eight complaints of weld failures, the company failed to document sufficient detail to describe the complaints, including whether the de vices were used on patients and whether any complications occurred, and to include in the complaint file adequate records of complaint investigations. QC/QS, Val; C-H; Doc. 14109W

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