inforMED
MalfunctionFOS

VYGON

Received May 8, 2025 · Event occurred Apr 19, 2025

Report 21984663 · MDR key 21984663

Device

Generic name

Catheter, Umbilical Artery

Manufacturer

Vygon S A

Model number

1274.14

Catalog number

1274.14

Lot number

OTHERS ON SHELF ARE 031024EI

Product problems

  • Flushing Problem
  • Retraction Problem
  • Device Markings/Labelling Problem

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

NNP [NEONATAL NURSE PRACTITIONER] WAS PLACING AN UMBILICAL VENOUS CATHETER. THE NUMBERS ON THE CATHETER WORE OFF AS SOON AS SHE TOUCHED THEM. IT WAS DIFFICULT FOR HER TO KNOW HOW DEEP THE LINE WAS. WAS NOT REMOVED FROM SERVICE AS CATHETER WAS ALREADY INSERTED INTO UMBILICUS AND CATHETER WAS FUNCTIONAL. WAS MORE BENEFICIAL TO BABY TO LEAVE IN RATHER THAN REPLACE WITH A NEW CATHETER. DEPTH WAS ESTIMATED. INITIALLY HAD ISSUE FLUSHING AND DRAWING BACK ON CATHETER. LINE WAS PULLED BACK TO LOW LYING AND THEN REMOVED WHEN PIV [PERIPHERAL INTRAVASCULAR LINE] WAS PLACED. (UNFORTUNATELY, PACKAGING AND DEVICE WERE BOTH DISCARDED.)