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Catalog Number 5733690 |
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 09/12/2023 |
Event Type
malfunction
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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 device has not been returned to the manufacturer for evaluation.However, a video was provided for review.The investigation of the reported event is currently underway.H11: section a through f - the information provided by bd represents all of 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 sometime post dialysis catheter placement, the leakage was allegedly found from the extension line below the hub area.It was further reported that a crack was allegedly found in the extension line.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: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one 19cm hemosplit d/l catheter in two segments was returned for evaluation and one video was provided for review.Gross visual, microscopic, tactile and functional evaluations were performed on the returned device.A small split was noted in the extension leg under microscopic view.Upon infusion of the blue luer, a leak was observed from the extension leg, distal to the bifurcate.The video shows blood leaking from the extension leg.Therefore, the investigation is confirmed for the reported fracture and fluid leak issues.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: h6 (method, 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 sometime post a dialysis catheter placement, the leakage was allegedly found from the extension line below the hub area.It was further reported that a crack was allegedly found in 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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