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Catalog Number 6393230 |
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 10/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that three days post dialysis catheter placement, the leakage was allegedly found in the catheter from the extension line below the hub area.There was no reported patient injury.
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Manufacturer Narrative
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H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide 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: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 23cm glidepath d/l catheter was received for evaluation and one electronic photo was provided for review.Functional, gross visual, tactile and microscopic evaluations were performed.A split was noted on the red luer extension leg.An in-house syringe was attached to the red luer and upon infusion, a leak from the split on the extension leg was noted.Aspiration was attempted and was unsuccessful.Therefore, the investigation is confirmed for the reported fracture and fluid leak issue.The photo review also confirms the same.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.H11: section a through f ¿ the information provide 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 : see h10.
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Event Description
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It was reported that three days post a dialysis catheter placement, a leakage was allegedly found from the extension line below the hub area.It was further reported that crack was noted on the extension line.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
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Search Alerts/Recalls
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