Catalog Number 0250070500 |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 04/07/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacturer date is not known at this time.However, should it become available it will be provided in future reports.
|
|
Event Description
|
It was reported that there was foreign material inside the sterile packaging.
|
|
Manufacturer Narrative
|
This complaint investigation was closed based on the device not received, therefore the reported failure mode was not confirmed.In the event that the device is received, the complaint will be reopened and the investigation will be updated with new results.Alleged failure: foreign substance in packaging.Probable root cause: manufacturing/assembly/ service error.Incorrect or inadequate packaging.Severe shipping conditions.User error.The reported failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported that there was foreign material inside the sterile packaging.
|
|
Search Alerts/Recalls
|