inforMED
InjuryFOS

DUAL LUMEN 3.5FR POLYURETHANE UMBILICAL CATHETER

Received Jun 2, 2022 · Event occurred Apr 20, 2022

Report 3007697249-2022-00001 · MDR key 14576388

Device

Generic name

Umbilical Catheter

Model number

P2UVC3.5

Lot number

220125

Product problems

  • Break
  • Stretched
  • Break
  • Stretched

Patient

5 DA · Unknown

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

Narrative

Description of Event or Problem

THE UMBILICAL CATHETER WAS REPORTED TO HAVE BEEN PLACED IN THE UMBILICAL VEIN OF A NEWBORN BABY. AFTER SUCCESSFULLY COMPLETING THE COURSE OF THERAPY, THE CATHETER WAS REMOVED. UPON EXTRACTION, THE NNP NOTICED THAT THE TIP APPEARED JAGGED AND STRETCHED. CONCERNED THAT THE TIP MAY HAVE BROKEN OFF IN THE PATIENT, AN X-RAY WAS PERFORMED WHICH REVEALED NO INDICATION OF A PIECE OF THE CATHETER BEING LEFT INSIDE THE PATIENT. PER THE HOSPITAL, NO PATIENT HARM WAS FOUND AND NO FURTHER ACTIONS WERE TAKEN.

Additional Manufacturer Narrative

INVESTIGATION INCLUDED REVIEW OF THE RETURNED DEVICE AND A SAMPLE FROM ANOTHER LOT OF LIKE PRODUCT IN AN ATTEMPT TO REPRODUCE THE FAILURE MODE. THE INVESTIGATION CONCLUDED THAT TENSION APPLIED TO THE DEVICE DURING REMOVAL OF THE CATHETER AGAINST THE SUTURE CAUSED STRETCHING OF THE DISTAL 4CM AND CUTTING OFF OF THE LAST 0.5MM OF THE CATHETER. THE INVESTIGATION INDICATED NO EVIDENCE OF MANUFACTURING RELATED ISSUES THAT COULD HAVE CONTRIBUTED TO THE EVENT.