C. R. BARD, INC. GROSHONG 3 FR SINGLE-LUMEN PICC CATHETER, FULL PROCEDURE SAF; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
|
Back to Search Results |
|
Catalog Number 7717307 |
Device Problems
Occlusion Within Device (1423); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 10/26/2014 |
Event Type
malfunction
|
Event Description
|
Patient required multiple line insertions after original devices occluded, were repaired, and then failed again.This occurred over an approximate 4 week period of time.With each event, the line would not draw back or flush.Problems occurred at different times after line insertion: as few as 1 day after insertion and as long as 7 days after insertion.This facility has had multiple patients with this device and who are experiencing the same type of problem: the device is occluding and requiring repair at a higher rate than expected.The problem has been occurring over approximately 4 consecutive months.Only the 3 french size lines are affected.There are no similar patient common denominators and the type of fluids/medications given through the line varies by patient.The staff are following the manufacturer's instructions for flushing and caring for the lines.When patients with this device have occluded lines that cannot be repaired, a new line placement is required in order to continue therapy.The manufacturer has been notified with each event.The hospital is still waiting for the manufacturer to respond.
|
|
Search Alerts/Recalls
|
|
|