Model Number IPN046311 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/29/2020 |
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 fluid leakage at the level of the piston of the lor syringe.By the way user can continue the procedure.
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Manufacturer Narrative
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(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 (b)(4) (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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Event Description
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It was reported that fluid leakage at the level of the piston of the lor syringe.By the way user can continue the procedure.
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Event Description
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It was reported that fluid leakage at the level of the piston of the lor syringe.By the way user can continue the procedure.
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Manufacturer Narrative
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(b)(4).The customer reported the lor syringe leaked.The customer returned one lidstock that matched the kit and lot #'s reported for this complaint.No lor syringe was returned.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 lor syringe sample was returned for analysis, only the lidstock was returned.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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