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Catalog Number 6393190 |
Device Problems
Fluid/Blood Leak (1250); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/12/2024 |
Event Type
malfunction
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Event Description
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It was reported that during a dialysis catheter placement procedure, the catheter allegedly had fluid leakage.It was further reported that the dialysis machine was allegedly detected with an air emboli in the catheter.There was no reported patient injury.
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Manufacturer Narrative
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As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.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 : device pending return.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported fluid leak and air in the device issues as no objective evidence was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 05/2025), g3, h6 (method) h11: h6 (result, conclusion) 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 a dialysis catheter placement procedure, the catheter allegedly had fluid leakage.It was further reported that the dialysis machine was allegedly detected with an air emboli in the catheter.There was no reported patient injury.
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Search Alerts/Recalls
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