DOVER
Received Feb 13, 2025 · Event occurred Jan 22, 2025
Report 1423537-2025-00076 · MDR key 21374157
Device
Generic name
Urinary Drainage Collection Kit
Manufacturer
Cardinal Health, Inc.Model number
P4P16XSDCatalog number
P4P16XSD
Lot number
2413400864
Product problems
- Unintended Deflation
- Unintended Deflation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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
THE CUSTOMER REPORTED THAT BALLOON INFLATED PER MANUFACTURING INSTRUCTIONS. NO RESISTANCE WAS NOTED ON INFLATION. THE SECUREMENT DEVICE DID NOT WORK AS CATHETER HAD FALLEN OUT. THE BALLOON APPEARED TO HAVE POPPED. THERE WAS NO HARM REPORTED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) FOR LOT 2413400864 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THERE WERE NO PHOTOS OR PHYSICAL SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.