(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 (reference files (b)(4)).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, "leakage found by normal handling, manipulation of plunger increases leakage".A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per (b)(4) (released 03-dec-2018), supplier (preox) made the following changes: kz-05501-002 luer plastic lor syringe: changed plunger material from profax 535 to profax 531.Changed to new plunger tool.Changed to new mold for blue stopper.Changed molding location for the plunger and the blue stopper as follows.Plunger: from fleimaplastic in germany to gpe, germany.Blue stopper: from et, germany to psilkon, germany.These effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.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, "leakage found by normal handling, manipulation of plunger increases leakage".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.
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