Catalog Number JC-05400-B |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Information (3190)
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Event Date 07/20/2020 |
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 there was no resistance with the syringe because the plunger, at the level of the blue tip, was leaking.Same issue as the one that led to the recall for this device in march 2020.The lot# involved is not part of that recall.Clinical consequences: difficult to know if we are in the epidural space.Delay in the treatment.
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Event Description
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It was reported that there was no resistance with the syringe because the plunger, at the level of the blue tip, was leaking.Same issue as the one that led to the recall for this device in (b)(6)2020.The lot# involved is not part of that recall.Clinical consequences: difficult to know if we are in the epidural space.Delay in the treatment.
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Manufacturer Narrative
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Qn#(b)(4).A device history record review was performed on the lor syringe with no relevant findings.A design history review was performed for part # kz-05501-002 as a part of this complaint investigation.Per eco-057562 (released (b)(6)2020 ), supplier (preox) made the following changes: optional component materials/mold locations: option 1: barrel: polypropylene - profax pf-535 lyondell-basell plunger: polypropylene 100-ga12 ineos olefins & polymers (molded at fleima plastic) blue stopper: silicone rubber (molded at et elastomer technik) option 2: barrel: polypropylene - profax pf-535 lyondell-basell plunger: polypropylene profax pf-531 lyondell-basell (molded at gpe) blue stopper: silicone rubber (molded at psilkon) lubricant: - the i.D.Of the barrel lubricated w/ medical grade silicone (polydimethylsiloxan) and amount will not exceed 0.25mg per sq centimeter.These effective changes did impact product design and material.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and without the actual sample.Complaint verification testing could not be performed as no sample was provided for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without the sample.
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Search Alerts/Recalls
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