Model Number 0070320 |
Device Problem
Unclear Information (4052)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/21/2021 |
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.The device was not returned.
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Event Description
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It was reported that there was no black marker to indicate length the wound drain.Per follow up information received via ibc on 28jul2021, there was no photo sample and it was reported that there was no scales on the device.
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Manufacturer Narrative
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The reported event was inconclusive as no sample returned for evaluation.A potential root cause for this failure mode could be due to omitted operation.It was unknown whether the device had met specifications.The product was not used on a patient but it was unknown whether the product had caused the reported failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.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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Event Description
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It was reported that there was no black marker to indicate length of the wound drain.Per follow up information received via ibc on 28jul2021 there was no photo sample and it was reported that there was no scales on the device.
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Search Alerts/Recalls
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