Catalog Number A902214 |
Device Problem
Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/10/2023 |
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 solution inside of the syringe had a foreign substance.Issue was noticed before use.
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Manufacturer Narrative
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The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "no follow up to cleaning procedure in the production areas".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because 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.
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Event Description
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It was reported that the solution inside of the syringe had a foreign substance.Issue was noticed before use.
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Search Alerts/Recalls
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