Catalog Number A119216M |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2024 |
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 they had an issue with 10 cc syringe of sterile water in one of the foley trays.There was some kind of debris in the syringe.
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Event Description
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It was reported that they had an issue with 10 cc syringe of sterile water in one of the foley trays.There was some kind of debris in the syringe.Per additional follow up received via email on 06feb204, stated that it was noticed before use, and they pulled a new product for use on the patient.
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Manufacturer Narrative
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The reported event is confirmed cause unknown.Visual evaluation noted received 1 photo sample of syringe contained within biohazard bag.Syringe is full with solution and brown debris is present within the syringe.Therefore, the reported event is confirmed.Root cause could not be identified.Although a root cause could not be definitively identified, a potential root cause for this type of failure could be defective/contaminated components.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as 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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