ARGYLE
Received Jun 12, 2025 · Event occurred May 30, 2025
Report 1423537-2025-00243 · MDR key 22195333
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health 200, LlcModel number
8888160333Catalog number
8888160333
Lot number
2418300064
Product problems
- Break
- Connection Problem
- Break
- Connection Problem
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 THREADING ON PORTION OF THE CATHETER WHERE THE SYRINGE OR CONNECTORS INSERT WAS BROKEN OFF, THE CONNECTOR COULD NOT BE SECURED TO CATHETER. IT LOOKS AS IF THE UMBILICAL LINE APPARENTLY FAILED DUE TO THE THREADING ON THE CATHETER BEING CHANGED, AS THEY ARE NOW TABS INSTEAD OF THREADS. THERE IS NO PATIENT HARM REPORTED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) FOR LOT 2418300064 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE DEVICE WAS RECEIVED FOR EVALUATION AND THE REPORTED CONDITION WAS OBSERVED. A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.