inforMED
MalfunctionFOS

ARGYLE

Received Nov 7, 2024

Report 1423537-2024-00292 · MDR key 20631678

Device

Generic name

Catheter, Umbilical Artery

Model number

8888160333

Catalog number

8888160333

Lot number

2303100264

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

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

THE CUSTOMER REPORTED THAT THEY WERE NOT ABLE TO SECURELY ATTACH THE TUBING OR CLAVE TO UMBILICAL CATHETER HUB. PER CUSTOMER, THEY HAD PREVIOUSLY BEEN ABLE TO SECURE TUBING. THE CUSTOMER FURTHER STATED THAT WHEN THE LINE WAS REMOVED, THE HUB OF LINE FOUND TO BE BROKEN. THERE WAS NO HARM REPORTED.

Additional Manufacturer Narrative

THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT 2303100264 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE REPORTED LOT NUMBER WAS MANUFACTURED IN 2023 WITH THREAD DESIGN, HOWEVER ACCORDING TO THE REVIEW OF THE RETURNED DEVICE, THE HUB OF THE RETURNED DEVICE WAS A WING DESIGN. THEREFORE, THE LOT NUMBER REPORTED BY THE CUSTOMER DOESN¿T MATCH TO THE RETURNED DEVICE. UPON DEVICE EVALUATION, 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.