ARGYLE
Received Feb 10, 2026 · Event occurred Feb 4, 2026
Report 1423537-2026-00033 · MDR key 24310720
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health, Inc.Model number
8888160556Catalog number
8888160556
Lot number
2435200127
Product problems
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. SECTION E1: E-MAIL: (B)(6).
Description of Event or Problem
THE CUSTOMER REPORTED THAT ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETERS ARE NOT STAYING CONNECTED TO THE STOPCOCKS. IT OCCURS WITH EVERY ONE OF THEM THAT THEY HAVE OPENED. THE CONNECTOR ENDS DO NOT LOCK, THE TABS SEEM TO BE SLIPPING IN THE LUERLOCK OF THE STOPCOCKS. THEY JUST KEEP SPINNING, AND IF THEY APPLY ANY PULLING PRESSURE, THEY CAN PULL THEM RIGHT OUT. THERE WAS NO HARM REPORTED.
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) FOR LOT 2435200127 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.