(b)(4).A device history record review was performed on both the reported and received lot numbers for the lor syringe with no relevant findings.The customer reported the lor syringe leaked.The customer returned one sealed representative kit.Lot # 71f19g0974 was returned for investigation.The is different from the lot # reported on the complaint (71f19k2112) (reference files (b)(4)).The actual complaint sample was not received.The returned kit was opened and the 10ml plastic lor syringe was removed and was visually examined.Visual examination of the syringe revealed that the syringe appears typical with no observed defects or anomalies.Functional testing was performed on the returned syringe using the lab leak tester (c05176) per the parameters in amrq-000155 rev.6, section 7.2-positive pressure leakage.Water was aspirated into the syringe to the 8ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.A leak was detected.Water was removed from the syringe to the 2ml mark and the syringe was inverted to remove any air from the barrel.The tip of the syringe was then connected to the lab leak tester via tubing and pressure was applied.The syringe was tested at 10psi for 10 seconds.No leaks were detected.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: 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 new design.Syringe with no evidence to suggest a manufacturing related issue.However, based on the observed leak, the potential root cause of this issue is supplier related.A scar has been initiated to further investigate this issue.
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