|
Catalog Number 6393230 |
Device Problem
Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/25/2023 |
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, a photo and videos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2024) 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.
|
|
Event Description
|
It was reported that approximately two weeks post dialysis catheter placement, the catheter allegedly leaked at the extension part.Reportedly, the catheter was 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.Two videos were provided for review.The video shows the leakage of blood from the red luer extension leg.Therefore, the investigation is confirmed for the reported 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.H10: b5, d4 (expiry date: 11/2024), g3, h6 (method) h11: 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.
|
|
Event Description
|
It was reported that approximately two weeks post dialysis catheter placement, the catheter allegedly leaked at the extension part.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|