COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
|
Back to Search Results |
|
Model Number 8813817009 |
Device Problem
Occlusion Within Device (1423)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 04/26/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, pre-operatively, the guide wire cannot pass through the a (arterial) line.There was no reported patient injury.
|
|
Manufacturer Narrative
|
Evaluation summary: post market vigilance (pmv) led an evaluation of one device.The visual inspection of the returned product noted no abnormalities.Pmv performed functional testing which included submerging the catheter into a water bath.The end was clamped, and a syringe was used to inject air to observe leakage.No air bubbles were present.Both extensions were tested with acceptable results.The guide wire was inserted and removed and reinserted into the tube without restriction.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.A review of the device history record indicates the product was released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related failures.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during insertion before using it to the patient, the guide wire cannot pass through the a (arterial) line.It was stated that there was no damaged on the guide wire but the a line of the catheter was blocked.There was no patient injury.
|
|
Search Alerts/Recalls
|
|
|