Catalog Number AB-22050-SS |
Device Problems
Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/07/2019 |
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 the stimulating pnb needle of the catheter is leaking; there was a hole at the level of the insertion of the catheter and the injection system next to the neurostim.There may have been direct consequences for the patient (air injection, modified injected dose, degraded asepsis) and indirect (altered quality of ultrasound guidance by injection of air with less echogenicity).It happened at least with 3 different catheters with this lot# and at least 2 different doctors.
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Manufacturer Narrative
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Qn#(b)(4).After an additional medical review, a determination was made to re-classify the complaint as a malfunction.Complaint(b)(4) is being reported as a malfunction.There was no serious injury.
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Search Alerts/Recalls
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