(b)(4).The device history record of batch number 74d2101093 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.Five representative samples of catalog number dp-44k (pu dp-44k disp punch 4.4mm) were received in its original pouch sealed for analysis.Lot number 74d2101093 no visual issues were observed on samples that can lead to the issue reported.No gap between core and blade were observed when were functional inspected.The five representative samples were activated several times to verify that these slides softly without getting stuck according to work instruction wi-pun-022 rev.18 no functional issues were found.An additional test was performed on representative samples.This test is not part of current process.A foam and blade were used in this test.Five pieces of foam were cut with a blade, a slot like the diameter of punch tip, then the punch tip was placed through the cut, the punch was activated to create a cut in the foam.Then the foam was pull carefully away from the punch and the remaining foam material from the tip was removed from the punch.This test was applied to each sample.A complete circumferential cut was performed with each sample.Punch returns correctly without getting stuck in all samples customer complaint cannot be confirmed.There were no issues found with the returned representative samples.However, the actual sample was not returned.The root cause could not be determined without the actual sample returned for investigation.
|