Catalog Number JC-05400-B |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2019 |
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 a triple incident occurred on (b)(6) 2019 in the maternity room.Three different doctors faced the same issue with devices from the same lot number.They had difficulties inserting the catheter in the tuohy needle because there was a blockage at the level of the distal bevel.
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Event Description
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It was reported that a triple incident occurred on (b)(6) 2019 in the maternity room.Three different doctors faced the same issue with devices from the same lot number.They had difficulties inserting the catheter in the tuohy needle because there was a blockage at the level of the distal bevel.
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Manufacturer Narrative
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(b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.A corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter and needle with no relevant findings.The potential cause of catheter not threading could not be determined based upon the information provided and without a sample.
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Search Alerts/Recalls
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