Catalog Number CDC-42703-P1A |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
Event Type
malfunction
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Event Description
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It was reported that: "the e.D.Rn director reported that the.032 spring wire guide in the kit began to unravel, on the proximal end of the wire, during the insertion process.Entire wire was removed from the patient, without incident, & the catheter did end up being placed successfully." there was no reported patient harm or consequence.
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that: "the e.D.Rn director reported that the.032 spring wire guide in the kit began to unravel, on the proximal end of the wire, during the insertion process.Entire wire was removed from the patient, without incident, & the catheter did end up being placed successfully." there was no reported patient harm or consequence.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
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Search Alerts/Recalls
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