ARGYLE
Received Oct 15, 2024 · Event occurred Oct 3, 2024
Report 1423537-2024-00235 · MDR key 20457864
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health, Inc.Model number
8888160333Catalog number
8888160333
Lot number
2410500063
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
THE DEVICE HISTORY RECORD (DHR) FOR LOT 2410500063 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE DEVICE WAS RECEIVED FOR EVALUATION AND REPORTED ISSUE OF BREAKAGE WAS NOT OBSERVED; HOWEVER, THE REPORTED CONDITION OF CANNOT CONNECT TO HUB 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
PER CUSTOMER, THE NURSING STAFF REPORTED THAT THE TUBING WOULD NOT ATTACH SECURELY TO UMBILICAL LINE. THE HUB OF LINE FOUND TO BE BROKEN. THE ISSUE WAS REPORTED TO THE PROVIDER AND THE LINE WAS REMOVED SINCE IT WAS UNABLE TO SECURELY CONNECT. THERE WAS NO HARM REPORTED.