(b)(6).
Results: one used samples was returned for evaluation.
A visual inspection revealed the returned unit was a section of a broken catheter.
No unit package or other parts of the device were returned.
A microscopic inspection revealed that the returned catheter was 25 mm long and the cross section and profile were uneven and irregular with signs of pulling and shrinkage.
The internal and outer diameter of the catheter was measured and no abnormalities were observed.
A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6111459.
A manufacturing review revealed no abnormalities with incoming material, assembly, or packaging processes.
Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
(b)(4).
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