Model Number IPN923527 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/03/2023 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: n/a.Corrected data: n/a.
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Event Description
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"it was reported that the user was unable to insert a guidewire through the catheter during use.Therefore, the catheter was replaced with a new kit of the same catalog and lot number, inserted at the same insertion site to complete the procedure.No injury to the patient was reported." patient condition is reported as "fine".
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.Other remarks: n/a.Corrected data: n/a.
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Event Description
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"it was reported that the user was unable to insert a guidewire through the catheter during use.Therefore, the catheter was replaced with a new kit of the same catalog and lot number, inserted at the same insertion site to complete the procedure.No injury to the patient was reported." patient condition is reported as "fine".
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Search Alerts/Recalls
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