Investigation summary: 3 representative samples were collected for investigation on 01/10/2018.The samples were not decontaminated.The 3 representative samples were subjected to the breakout and sustaining force test per (b)(4).The 3 representative samples passes the breakout and sustaining force test.Did the returned samples show the reported defect? no.Dhr review: the reviewed syringe device history record showed no quality notification was raised for the reported nonconformance.The routine silicon test passed the specifications.Manufacturing review: reviewed preventative maintenance, calibration, and equipment had no abnormality observed that could have influenced the issue.Conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure mode.Is the product within specification? yes.Root cause: reviewed the dhr; routine silicon test and breakout and sustaining force test passed the specifications.The 3 returned representative samples passed the breakout and sustain force test.Root cause could not be determined.No capa is required.
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