Investigation summary: one actual sample in open package received on 01/10/2018 and forty two representative samples were also collected for investigation.The samples were not decontaminated.The actual sample and 42 representative samples were subjected to the breakout and sustaining force test per (b)(4).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 1 actual sample and 42 representative samples passed the breakout and sustain force test.Root cause could not be determined.No capa is required.
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