Catalog Number SAC-00522-PBX |
Device Problem
Unraveled Material (1664)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/16/2024 |
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 "the swg tangles on the needle, and when trying to move backwards the swg it broke".No patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
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Event Description
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It was reported "the swg tangles on the needle, and when trying to move backwards the swg it broke." no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine.".
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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.The ifu was reviewed, and it informs the user not to retract the guide wire against the needle bevel.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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