(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 (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 ((b)(4)) for function testing.According to the supplier, no leak was found with the returned sample.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-051699 (released 03-dec-2018), supplier ((b)(4)) made the following changes: kz-05501-002 luer plastic lor syringe: a.Changed plunger material from profax 535 to profax 531.B.Changed to new plunger tool.C.Changed to new mold for blue stopper.D.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 old design.The reported complaint of the lor syringe leaking could not be confirmed based on the sample received.The returned lor syringe was returned to the supplier ((b)(4)) for functional testing where no issues were found.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.Based on the supplier's results, no issues were found with the returned sample.
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