Model Number 384540 |
Device Problems
Crack (1135); Fluid/Blood Leak (1250)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
malfunction
|
Event Description
|
We have another leaking picc line that had to be removed from a patient.This one is the smaller gauge.
|
|
Manufacturer Narrative
|
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
|
|
Manufacturer Narrative
|
A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection confirmed a crack in the luer that would result in leakage.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.
|
|
Event Description
|
We have another leaking picc line that had to be removed from a patient.This one is the smaller gauge.
|
|
Search Alerts/Recalls
|