inforMED
InjuryFOS

ARGYLE 5FRENCH CATHETER

Received Jun 11, 2026 · Event occurred Dec 3, 2024

Report MW5189330 · MDR key 25471976

Device

Generic name

Catheter, Umbilical Artery

Lot number

2422207434

Patient

NA · Unknown

  • Discomfort

Narrative

Description of Event or Problem

PATIENT HERE FOR VCUG AND FOLLOW UP APPOINTMENT. COVIDIEN ARGYLE 5FR/CH CATHETER, LOT # 2422207464, EXP 7-31-29 WAS INSERTED BY RADIOLOGIST FOR VCUG. NO URINE RETURN NOTED, US TECH CHECKED PLACEMENT VIA US WHICH SHOWED CATHETER IN THE BLADDER. PATIENT THEN PEED AROUND CATHETER. CONTRAST WAS HOOKED UP CATHETER AND ATTEMPTED TO INSTILL. AFTER TUBING WAS UNCLAMPED, THE CONTRAST DID NOT FLOW. CATHETER WAS REMOVED AND NEW CATHETER WAS INSERTED (FROM SAME LOT) AND URINE RETURN WAS NOTED IMMEDIATELY AFTER INSERTION. DEFECTIVE CATHETER WAS TESTED BY ATTEMPTING TO FLUSH SALINE. UNABLE TO FLUSH CATHETER. THIS RESULTED IN THE PATIENT BEING CATHETERIZED TWO TIMES INSTEAD OF ONCE, WHICH WAS UNCOMFORTABLE FOR PATIENT AND PARENTS. IT ALSO POSES A GREATER RISK FOR A UTI TO OCCUR. (B)(4).