Catalog Number CDC-41541-MPKB |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2023 |
Event Type
malfunction
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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: glide thru peel away sheath broke at the handle, on the proximal portion of the sheath.The nurse used her fingers to carefully separate and peel away the remaining sheath body.She was able to complete the procedure.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.Additional information: the insertion site was in the upper arm.The entire sheath was confirmed to have been removed.
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Manufacturer Narrative
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Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and there was one potential finding.Without the sample returned, it cannot be confirmed if the failure mode of this complaint is the same as/relevant to the finding.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Event Description
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It was reported that: glide thru peel away sheath broke at the handle, on the proximal portion of the sheath.The nurse used her fingers to carefully separate and peel away the remaining sheath body.She was able to complete the procedure.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.Additional information: the insertion site was in the upper arm.The entire sheath was confirmed to have been removed.
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Search Alerts/Recalls
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