Catalog Number JC-05400-B |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/01/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
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Event Description
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It was reported that when starting the epidural, the anesthesiologist observed that the plunger has no resistance therefore there is no awareness when inserting the catheter.No lot number has been identified as the issue affects different lots received.After comparing 2 plungers, we observed that the ones not working have a pointier tip and are less rigid than the ones working.
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Event Description
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It was reported that when starting the epidural, the anesthesiologist observed that the plunger has no resistance therefore there is no awareness when inserting the catheter.No lot number has been identified as the issue affects different lots received.After comparing 2 plungers, we observed that the ones not working have a pointier tip and are less rigid than the ones working.
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Manufacturer Narrative
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Qn#(b)(4).A device history record review could not be performed as no lot number was provided by the customer.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 customer also provided a photo.The returned sample was returned to the supplier (preox) 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 (b)(4) (released (b)(6)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 (b)(4), germany.These effective changes did impact product design and material.It should be noted, the returned lor syringe was from the new design.The returned sample was returned to the supplier (preox) for functional testing.No issues were found with the returned sample.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 (preox) for functional testing where no issues were found.A device history record review could not be performed as no lot number was provided by the customer.Based on the supplier's results, no issues were found with the returned sample.
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Search Alerts/Recalls
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