C.R. BARD, INC. (BASD) -3006260740 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Model Number 1608062 |
Device Problems
Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/14/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that sometime post port placement procedure, the port needle was allegedly dislodged from port when receiving chemotherapy through the port.It was further reported that extravasation of chemo solution occurred.Reportedly, the needle locked into the port and did not come out.There was no reported patient injury.
|
|
Manufacturer Narrative
|
As the lot number for the device was provided, a review of the device history records was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 01/2023).
|
|
Search Alerts/Recalls
|
|
|