DOVER
Received Apr 7, 2026 · Event occurred Mar 31, 2026
Report 1423537-2026-00104 · MDR key 24809296
Device
Generic name
Catheter, Urological
Manufacturer
Cardinal Health 200, LlcModel number
8888492033Catalog number
8888492033
Product problems
- Material Twisted/Bent
Patient
NA · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
ACCORDING TO THE CUSTOMER, THE PATIENT STATED THAT DUE TO ALL SUPPLIES STUFFED IN 1 BOX, THEY WERE BENT AND SHE COULD NOT STRAIGHTEN THEM OUT. THERE WAS NO HARM REPORTED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED SINCE NO LOT NUMBER WAS PROVIDED. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED TO DETERMINE THE ROOT CAUSE.¿WE WILL CONTINUE TO MONITOR REPORTS AND TAKE ACTIONS AS APPLICABLE.