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Catalog Number 6393420 |
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 07/16/2023 |
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 photo 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.
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Event Description
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It was reported that during a dialysis catheter placement procedure, there was allegedly leakage in the hub of the catheter.The procedure was completed using another device.There was no reported patient injury.
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Event Description
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It was reported that during a dialysis catheter placement procedure, there was allegedly leakage in the hub of the catheter.The procedure was completed using another device.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 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: 01/2024), g3.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.
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Manufacturer Narrative
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H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: the sample was not returned for evaluation.One electronic photo was provided for review.The photo shows a partial break on the extension legs proximal to the bifurcation site and near the clamps.Blood was noted to be leaked and clotted in the partial break near the clamps.Therefore, the investigation is confirmed for the reported fluid leak and the identified fracture issues.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: 01/2024), g3, h6 (device, method) h11: b5, h6 (result, conclusion) 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 not returned.
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Event Description
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It was reported that sometime post a dialysis catheter placement, there was allegedly a leakage in the hub of the catheter.The procedure was completed using another device.There was no reported patient injury.
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Search Alerts/Recalls
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