|
Catalog Number 6393230 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/17/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
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, photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 05/2025).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.
|
|
Event Description
|
It was reported that sometime post dialysis catheter placement procedure, the catheter was allegedly broke at clamping site.It was further reported that catheter allegedly leaked.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
|
|
Event Description
|
It was reported that approximately two months post a dialysis catheter placement, the catheter was allegedly broken at the clamping site.It was further reported that the catheter allegedly leaked.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
|
|
Manufacturer Narrative
|
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.One photo was provided for review.The photo shows the partial view of the implanted catheter in which the extension legs were filled with blood.Therefore, the investigation is inconclusive for the reported fracture and fluid leak issues as no evidence of fracture and fluid leak were noted from the provided photo.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.H10: d4 (expiration date: 05/2025), g3, h6 (method).H11: b5, 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.H3 other text : device not returned.
|
|
Search Alerts/Recalls
|
|
|