Catalog Number 786426 |
Device Problem
Wrong Label (4073)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2023 |
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 the customer opened the package during the operation and found that the stent catheter was 426 model, but the push tube was 626, which could not be matched for normal use.
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Event Description
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It was reported that the customer opened the package during the operation and found that the stent catheter was 426 model, but the push tube was 626, which could not be matched for normal use.
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Manufacturer Narrative
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The reported event is inconclusive as the original packaging was not returned.Visual evaluation noted received 1 stent with no original packaging.Returned size of stent is 4.7 f x 26 cm.As original packaging was not returned the reported event cannot be confirmed.Although an exact root cause could not be determined a potential root cause could be incorrect line clearance.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labelling review is not required as the labelling would not have prevented the reported event.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 actual/suspected device was inspected.
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Search Alerts/Recalls
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