inforMED
InjuryPPG

100% SILICONE URINE METER FOLEY TRAY (DOVER) - 16 FR/CH

Received Nov 21, 2024 · Event occurred Nov 13, 2024

Report MW5162787 · MDR key 20758011

Device

Generic name

Urinary Drainage Collection Kit

Model number

P4P16SD

Catalog number

(10) 2413514364

Lot number

(01) 10192253031805

Patient

34 YR · Female

  • Internal Organ Perforation
  • Internal Organ Perforation

Narrative

Description of Event or Problem

PREGNANT PATIENT EXPERIENCED A BLADDER PUNCTURE FROM THE BULB TIP OF THE SILICONE FOLEY CATHETER. DURING A C-SECTION PROCEDURE, THE OB(OBSTETRICS) SURGEON DETECTED THAT THE FOLEY BULB WAS CLEARLY VISIBLE UPON PERITONEAL ENTRY. OF NOTE, THE PATIENT'S BLADDER WAS ADHERENT TO THE PERITONEUM/ANTERIOR ABDOMEN WALL, AND IT WAS EXTREMELY THIN AND ATTENUATED. THERE WAS AN ATTEMPT TO TRY TO PULL THE FOLEY TUBING BACK TO TRY TO RETRACT THE FOLEY BULB INTO A LOWER POSITION, HOWEVER, THE FOLEY TIP PUNCTURED THROUGH THE THIN BLADDER WALL CREATING A 5CM CYSTOTOMY AT THE DOME. THE CYSTOTOMY WAS SURGICALLY REPAIRED BY A UROLOGY SURGEON IMMEDIATELY AFTER THE C-SECTION.