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
Fracture (1260); Material Separation (1562); Suction Problem (2170)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/25/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H10: as the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos and an image were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 10/2022).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 two years, eight months and twenty-seven days post a port placement via the right internal jugular vein, the device allegedly had resistance and the blood could not be withdrawn.It was further reported that under chest x-ray examination, the catheter was allegedly found to be broken at two centimeters above the clavicle and near the puncture point.Furthermore, the port and the port body which was five centimeters from the tip of the catheter were immediately removed by surgery.However, the remaining catheter was removed by a catcher after consultation with the interventional department.There was no reported patient injury.
|
|
Search Alerts/Recalls
|
|
|