Catalog Number 787626 |
Device Problem
Wrong Label (4073)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
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 reported that during the surgery, the doctor used the ureteral stent and disassembled it to find that the actual product did not match the specifications in the package, which affected the use and was replaced immediately.
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Event Description
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It was reported that during the surgery, the doctor used the ureteral stent and disassembled it to find that the actual product did not match the specifications in the package, which affected the use and was replaced immediately.
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Manufacturer Narrative
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The reported event is inconclusive as no sample was returned for evaluation.Although an exact root cause could not be determined a potential root cause could be wrong line clearance.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labelling review is not required as labelling would not have prevented the reported event.Correction: e.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.H3 other text : the device was not returned.
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Search Alerts/Recalls
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