DOVER
Received Apr 14, 2026 · Event occurred Mar 21, 2026
Report 1423537-2026-00108 · MDR key 24873755
Device
Generic name
Catheter, Urological
Manufacturer
Cardinal Health 200, LlcModel number
1616Catalog number
1616
Product problems
- Unintended Deflation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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.
Description of Event or Problem
THE CUSTOMER REPORTED THAT TWO OF THE CATHETERS FROM THE SAME PATIENT FELL OUT WITHIN A DAY OR TWO OF INSERTION WITH DEFLATED BALLOONS; AS PER PRODUCT INSTRUCTION, 10 ML OF NORMAL SALINE (NS) INFLATED INTO THE BALLOON. THE CUSTOMER FURTHER STATED THAT THE REGISTERED NURSE (RN) TESTED ANOTHER 16 FR CATHETER, THEY LEFT IT OUT IN THE MED ROOM TO MONITOR UNTIL THE MORNING AND IDENTIFIED IT HAD BEEN LEAKING ALL EVENING AS EVIDENCED BY MOISTURE AND WETNESS AT THE BALLOON AND DECREASE IN SIZE. THERE WAS NO HARM TO THE PATIENT INVOLVED.