C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER
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Catalog Number 119314 |
Device Problem
Burst Container or Vessel (1074)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that there was no problem in the balloon expansion test, but after inserting the foley catheter, a large amount of sterile water leaked out.It seems that the balloon part was damaged.The balloon was torn.There was no reported patient injury.Per additional information via email from ibc on 01apr2024, it was stated that the balloon was damaged.
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Search Alerts/Recalls
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