MalfunctionFFH

CATHETER KIT

Received Nov 25, 2025 · Event occurred Sep 5, 2025

Report 23644319 · MDR key 23644319

Device

Generic name

Collector, Urine, Pediatric, For Indwelling Catheter

Manufacturer

C.r. Bard Inc.

Lot number

NGJW2398 AND NGJV1962

Product problems

Fluid/Blood Leak
Detachment of Device or Device Component

Patient

12 MO · Male

Exposure to Body Fluids
Exposure to Body Fluids

Narrative

Description of Event or Problem

CATH KIT HAS DEFECT WHERE THE CATHETER FALLS OUT OF THE COLLECTION CONTAINER DURING THE PROCEDURE. THIS HAS CAUSED URINE TO SPILL OUT OF THE CONTAINER MID-COLLECTION, IN ONE INSTANCE VIOLATED THE STERILE FIELD, AND HAS RESULTED IN US HAVING TO OPEN SEVERAL KITS FOR SOME PATIENTS. WE HAVE TWO SEPARATE EXAMPLES RIGHT NOW WITH TWO LOT NUMBERS: NGJW2398 AND NGJV1962.