(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe leaked.The customer returned one 10ml plastic lor syringe and lidstock (reference files inp1900073955).The syringe was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.The returned sample was returned to the supplier (preox) for function testing.According to the supplier, "no leakage found by normal handling, leakage if plunger moved to the side".The reported complaint of the lor syringe leaking was confirmed based on the sample received.The returned lor syringe was returned to the supplier (preox) for functional testing where according to the supplier, "no leakage found by normal handling, leakage if plunger moved to the side".A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.However, based on the functional testing by the supplier, the potential root cause of this issue is supplier related.A scar has been initiated to further investigate this issue.
|