C.R. BARD, INC. (COVINGTON) -1018233 BARD® INLAY® URETERAL STENT WITH HYDROGLIDE¿ GUIDEWIRE
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Catalog Number 777626 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/06/2023 |
Event Type
malfunction
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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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Event Description
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It was stated that the stent breaked when the stent was unpacked.It was noted that the when the stent was disassembled, the stent was broken, which affects the progress of the operation and increases the cost of the operation.It was also noted that the surgery was delayed due to device broken.
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Manufacturer Narrative
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The reported event is inconclusive as no sample was returned for evaluation.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be user does not handle with care, bends sharply.However, there was insufficient information to confirm this potential root cause.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "improper handling technique can seriously weaken the stent." "exercise care.Tearing of the stent can be caused by sharp instruments." "care should be exercised when removing the stent from inner polybag so as not to cause tearing or fragmentation." "the insertion of a ureteral stent should only be done by those individuals who have comprehensive training in the techniques and risks of the procedure." 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.The device was not returned.
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Event Description
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It was stated that the stent breaked when the stent was unpacked.It was noted that the when the stent was disassembled, the stent was broken, which affects the progress of the operation and increases the cost of the operation.It was also noted that the surgery was delayed due to device broken.
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Search Alerts/Recalls
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