(b)(4).The rt021 catheter mount is sold in the usa but has no 510(k) number as it is considered a class i device.Method: the complaint rt021 catheter mount was returned to fisher & paykel heathcare (b)(4) for investigation, where it was visually inspected.Our investigation is also based on our knowledge of the product and investigations of past similar complaints.Results: visual inspection revealed that the tubing cuff of the catheter mount had split at the swivel end.A lot check revealed no other complaints of this nature for lot 160222.Conclusion: based on the investigation conducted, the split observed is likely due to environmental stress cracking caused by not fully cured primer.All rt021 catheter mounts are pressure tested prior to release for distribution.Any catheter mount with a split tube would have failed the pressure test and be rejected from the production line.Our user instructions that accompany the rt021 catheter mount state the following: check all connections are tight before use.Perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.
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