|
Catalog Number 5833690 |
Device Problems
Fluid/Blood Leak (1250); Fracture (1260)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/07/2023 |
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 video was 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 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.
|
|
Event Description
|
It was reported that sometime post a dialysis catheter placement in the right internal jugular vein, a break was allegedly found at the outlet.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 sample was not returned for evaluation.One electronic video was provided for review.The video shows partial view of dialysis hemostar catheter implanted in the patient, both the extension legs was filled with blood.Physician holding left side of extension leg while moving the extension leg fracture was noted and blood was leaking from the fracture.Physician removing the leak blood through cotton swab.Therefore, the investigation is confirmed for the reported fracture and 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.H10: (expiration date: 11/2024).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.
|
|
Event Description
|
It was reported that sometime post a dialysis catheter placement in the right internal jugular vein, a break was allegedly found at the outlet.It was further reported that the catheter allegedly leaked.Reportedly, the catheter was removed and replaced.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|