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
Manufacturer
Cardinal Health 200, Llc.Model number
P4P16SDCatalog 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.