DOVER
Received Nov 17, 2025 · Event occurred Oct 30, 2025
Report 1423537-2025-00462 · MDR key 23573762
Device
Generic name
Urinary Drainage Collection Kit
Manufacturer
Cardinal Health 200, LlcModel number
6070Catalog number
6070
Lot number
2416314564
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
THE DEVICE HISTORY RECORD (DHR) FOR LOT 2416314564 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. A PICTURE AND A VIDEO WERE PROVIDED FOR ANALYSIS, AND UPON REVIEW, THE REPORTED ISSUE WAS OBSERVED. THE AFFECTED COMPONENT IS PRODUCED BY AN EXTERNAL SUPPLIER. PER SUPPLIER INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, AS THE PHYSICAL DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THAT THE ITEM INSIDE THE KIT WAS FAULTY. ACCORDING TO THE CUSTOMER, WHEN THEY INSERTED LIQUID INTO THE BALLOON, IT LEAKED. THERE WAS NO HARM REPORTED.