Catalog Number 46535BER |
Device Problems
Fracture (1260); Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/24/2022 |
Event Type
Injury
|
Event Description
|
The account alleges that during use, the catheter tip detached within the patient.The detached piece was successfully removed.No additional patient consequence to report.
|
|
Manufacturer Narrative
|
The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
|
|
Manufacturer Narrative
|
The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.
|
|
Search Alerts/Recalls
|