ARGYLE
Received Oct 15, 2024
Report 1423537-2024-00234 · MDR key 20453476
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health, Inc.Model number
8888160556Catalog number
8888160556
Lot number
2405900120
Product problems
- Fluid/Blood Leak
- Connection Problem
- Fluid/Blood Leak
- 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 2405900120 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. NINE SEALED, UNUSED DEVICES WERE RECEIVED FOR EVALUATION AND THE REPORTED ISSUE WAS NOT OBSERVED. AS PART OF CONTINUOUS IMPROVEMENT AND DUE TO THE SIMILAR COMPLAINTS RECEIVED FOR THE REPORTED ISSUE, 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 THAT THE CONNECTER DOESN'T HAVE A LIP TO SEED THE CONNECTION, SO IT CAN'T CONNECT TO A CLAVE PROPERLY WITHOUT LEAKING. THE ISSUE WAS DISCOVERED BEFORE USE. THERE WAS NO HARM REPORTED.