ARGYLE
Received Jul 9, 2024
Report 1423537-2024-00068 · MDR key 19705314
Device
Generic name
Catheter, Umbilical Artery
Manufacturer
Cardinal Health, Inc.Model number
8888160556Catalog number
8888160556
Lot number
2404400068
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
ADDED SECTION G3 / G4: PMA/510(K)NUMBER. SAMPLES WERE RECEIVED AT THE PLANT FOR THE INVESTIGATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. UPON A VISUAL EVALUATION OF THE SAMPLE, THE REPORTED ISSUE WAS CONFIRMED; THE ¿WINGS¿ OF THE HUB WAS VISIBLY WORN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME. HOWEVER, A CORRECTIVE AND PREVENTIVE ACTION HAS BEEN INITIATED TO ADDRESS THE REPORTED 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 THEY HAD TWO ISSUES IN OUR NICU DEPARTMENT INVOLVING THE ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER. THE INCONSISTENT DEPTH OF THE RING THAT LOCKS THIS CATHETER TO BREAK APART ON THIS LOT. FOR CLARIFICATION, WHERE YOU CONNECT THE TUBE/PARTS TOGETHER, IS NOT HOLDING TOGETHER. THE NURSE HAD TO REPLACE THE LINE