inforMED
InjuryFOS

2.5FR SINGLE LUMEN POLYURETHANE UMBILICAL CATHETER

Received Jun 23, 2023 · Event occurred Apr 19, 2023

Report 3007697249-2023-00002 · MDR key 17191937

Device

Generic name

Umbilical Catheter

Model number

P1UVC-2530

Lot number

UNKNOWN

Product problems

  • Break
  • Difficult to Remove
  • Break
  • Difficult to Remove

Patient

Unknown

  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions
  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING ATTEMPTS TO REMOVE THE CATHETER FROM THE PATIENT FOLLOWING COMPLETION OF USE, DIFFICULTY WAS EXPERIENCED. THE CATHETER WAS BROKEN DURING THE REMOVAL ATTEMPT WITH A PIECE REMAINING INSIDE OF THE PATIENT, WHICH WAS CONFIRMED BY X-RAY. THE REMAINING FRAGMENT WAS REMOVED BY OPERATION AND NO FURTHER COMPLICATIONS WERE REPORTED.

Additional Manufacturer Narrative

INVESTIGATION INCLUDED EVALUATING THE RETURNED PORTION OF THE DEVICE, WHICH INCLUDED THE DISTAL SEGMENT THAT HAD BEEN SURGICALLY REMOVED FROM THE PATIENT (THE PROXIMAL SEGMENT OF THE CATHETER WAS NOT AVAILABLE FOR REVIEW). THE LOT NUMBER WAS NOT REPORTED FOR THE PRODUCT INVOLVED IN THE EVENT. THE INVESTIGATION INDICATED NO EVIDENCE OF MANUFACTURING RELATED ISSUES THAT COULD HAVE CONTRIBUTED TO THE EVENT.