Model Number 384539 |
Device Problem
Crack (1135)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 05/20/2023 |
Event Type
malfunction
|
Event Description
|
Picc line cracked and leaking.
|
|
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
|
Picc line cracked and leaking.
|
|
Search Alerts/Recalls
|