Catalog Number 0220180518 |
Device Problems
Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Blood Loss (2597)
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Event Date 05/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
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Event Description
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It was reported that the surgeon cut across the patient ureter and the procedure was cancelled due to bleeding during the catheter insertion.
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Manufacturer Narrative
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This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: bleeding during the catheter insertion probable root cause: incorrect device dimensions.Incorrect catheter durometer.Incorrect device used.Manufacturing nonconformity.(e.G.Incorrect hydrophilic coating).Improper storage or shipping conditions the reported failure mode will be monitored for future reoccurrence.The device manufacturer date is not known at this time.H3 other text : 81.
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Event Description
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Update: it was reported that there was ureteral bleeding during the catheter insertion requiring treatment.It was reported that the surgeon cut across the patient ureter and the procedure was cancelleed due to bleeding during the catheter insertion.
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Search Alerts/Recalls
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