C.R. BARD, INC. (BASD) -3006260740 POWERPORT ISP MRI 6F CHRONW/OS; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 8806061 |
Device Problems
Collapse (1099); Fracture (1260); Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/22/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H10: as the lot number for the device was provided, a review of the device history record will 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.H10: d4 (expiry date: 01/2025).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 during a port placement procedure in the right chest subclavian via right internal jugular vein, when using the tunneling device to prepare the same layer of subcutaneous retraction to create a tunnel the rubber was allegedly collapsed, and catheter was allegedly found to be broken into two parts.Reportedly both broken segments were removed and replaced with another device.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|