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Catalog Number 6393190 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2024).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 : device not returned.
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Event Description
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It was reported that sometimes post dialysis catheter placement, the catheter tube allegedly broke.It was further reported that blood was coming through it.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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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 sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one catheter implanted in the patient body and a fracture was noted on the red luer extension leg proximal to the hub.Therefore, the investigation is confirmed for the reported fracture issue.However, the reported fluid leak issue determined to be inconclusive.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 (expiry date: 05/2024).H11: 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 sometimes post dialysis catheter placement, the catheter tube allegedly broke.It was further reported that blood was coming through it.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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Event Description
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It was reported that sometimes post dialysis catheter placement, the catheter tube allegedly broke.It was further reported that blood was coming through it.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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Manufacturer Narrative
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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 sample was not returned for evaluation, one electronic photo was provided for review.The photo shows one catheter implanted in the patient body and a fracture was noted on the red luer extension leg near the hub.Therefore, the investigation is confirmed for the reported fracture and fluid leak issue.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.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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Search Alerts/Recalls
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