Catalog Number ASK-05503-BWB |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/19/2020 |
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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Reported issue: customer noted they have had some issues with the luer lock glass syringes related to product quality.The threads on a few have been bent making it difficult/impossible to screw on to the tuohy needle.They have also had issues with leakage at the connection point, also consistent with the threads not lining up.
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Event Description
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Reported issue: customer noted they have had some issues with the luer lock glass syringes related to product quality.The threads on a few have been bent making it difficult/impossible to screw on to the tuohy needle.They have also had issues with leakage at the connection point, also consistent with the threads not lining up.
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Manufacturer Narrative
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(b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the lor syringe with no relevant findings.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 lot number was not provided.A device history record review was performed based upon a lot number from sales history data.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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