Catalog Number 3910-500-472 |
Device Problems
Patient-Device Incompatibility (2682); Insufficient Information (3190)
|
Patient Problems
Unspecified Infection (1930); Fungal Infection (2419)
|
Event Date 06/11/2021 |
Event Type
Injury
|
Event Description
|
It was reported that the patient had an infection requiring an additional procedure.
|
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.
|
|
Event Description
|
It was reported that the patient had an infection requiring an additional procedure.
|
|
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: infection.Probable root cause: design: sterilization cycle not capable of reducing bioburden at worst-case locations.Device design not able to be sterilized.Device packaging does not retain sterile barrier.Process: error in packaging or sterilization process.Application use past device/packaging shelf life.User contaminates device.Rough handling of sterile packaging.Use of expired product.The reported failure mode will be monitored for future reoccurrence.
|
|
Search Alerts/Recalls
|