ARGYLE
Received Oct 29, 2024 · Event occurred Oct 22, 2024
Report 1423537-2024-00273 · MDR key 20558623
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health, Inc.Model number
8888160333Catalog number
8888160333
Lot number
2409600117
Product problems
- Connection Problem
- Connection Problem
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 2409600117 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.
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem
THE CUSTOMER REPORTED THE POLYURETHANE UMBILICAL VESSEL CATHETER 3.5FR SINGLE LUMEN WAS UNABLE TO CONNECT TO STOPCOCK. THERE WAS NO HARM REPORTED.