(b)(4).A device history record review was performed based on potential lot numbers provided by the customer.A device history record review was performed on the lor syringe with no relevant findings.The customer reported "the plunger of the syringe remained in the hand of the anesthetist during the aspiration test." the customer returned one sealed representative kit from the same lot # as one of the lot #'s reported on the complaint (71f19j2204) for investigation (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 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.No leaks were detected.The plunger was rotated 45deg and the syringe was once again tested at 10psi for 10 seconds and no leaks were detected.This was performed by rotating the plunger 45deg until the plunger had rotated a full 360deg with no leaks 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 with the plunger being rotated 45deg until it had rotated a 360deg with no leaks being detected.The returned lor syringe was compared to a lab inventory syringe by sliding the plunger into the barrel of the syringe.The resistance of the returned lor syringe was comparable to the lab inventory syringe.The luer end of the returned syringe was capped.With the tip sealed, the lor syringe was tested for leaks by pushing the plunger into the barrel.This was performed at 8ml, 5ml, and 2ml by pushing the plunger and rotating 45deg until the plunger had rotated a full 360deg.No leaks or slippage of the plunger occurred.An attempt to remove the plunger from the barrel was performed.The plunger seal snapped back when attempting to remove from the barrel.This was also performed with a lab inventory syringe with the same results.This indicates the plunger seal was creating a vacuum with no issues.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 (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.A corrective action is not required at this time as the complaint could not be confirmed based upon the information provided and without the actual complaint sample.The representative sample received was functionally tested and visually inspected with no issue found.The reported complaint of the "the plunger of the syringe remained in the hand of the anesthetist during the aspiration test" could not be confirmed based on the sample received.The actual complaint sample was not returned; only a representative sample was received.The returned lor syringe passed functional testing including a leak test.Also, the returned lor syringe when compared to a lab inventory syringe had comparable resistance when sliding the plunger into the barrel of the syringe.A device history record review was performed based on a potential lot numbers provided by the customer.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related issue.A potential root cause could not be determined based upon the information provided or without the actual complaint sample.
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