Catalog Number 12773-02 |
Device Problem
Unsealed Device Packaging (1444)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/22/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
|
|
Event Description
|
It was reported that when the perclose prostyle device was going to be prepared for the procedure, the outer packaging with the sealed tray inside was unglued.The device was not used.There was no patient involvement.No additional information was provided.
|
|
Event Description
|
It was reported that when the perclose prostyle device was going to be prepared for the procedure, the outer packaging with the sealed tray inside was unglued.The device was not used.There was no patient involvement.No additional information was provided.Device analysis revealed a foreign piece of material inside the sealed tray.
|
|
Manufacturer Narrative
|
The device was returned for analysis.The reported missing seal was confirmed.A review of the manufacturing records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported missing seal was concluded to be related to a potential product quality issue.The contamination was concluded to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
|
|
Search Alerts/Recalls
|