Model Number IPN046311 |
Device Problem
Premature Separation (4045)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/27/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Qn# (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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The plunger of the lor syringe slides out of the syringe barrel without any force being applied.This issue was already noted on approximately 20 devices in a period from october to december.
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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 12-mar-2020), supplier ((b)(4)) 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 ("polydimethylsiloxane") and amount will not exceed 0.25mg per sq centimeter.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.No further action is required at this time.
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Event Description
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The plunger of the lor syringe slides out of the syringe barrel without any force being applied.This issue was already noted on approximately 20 devices in a period from october to december.
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Search Alerts/Recalls
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