inforMED
MalfunctionPPB

MEDLINE INDUSTRIES, INC.

Received May 5, 2026 · Event occurred Apr 22, 2026

Report 25080737 · MDR key 25080737

Device

Generic name

Foley Catheter Kit (excludes Hiv Testing)

Model number

URO175816

Catalog number

URO175816

Lot number

MULTIPLE -UNK

Patient

NA · Unknown

  • Hemorrhage/Blood Loss/Bleeding
  • Discomfort

Narrative

Description of Event or Problem

MULTIPLE COMPLAINTS: 1. THE NURSE WAS TAKING OUT THE CATHETER. THE NURSE NOTED THAT ONLY 9ML OF STERILE WATER WAS ABLE TO BE PULLED BACK IN THE SYRINGE. THE CATHETER WAS THEN CUT AND REMOVED FROM THE PATIENT. 2. CONNECTED A STERILE SYRINGE TO THE BALLOON PORT AND ALLOWED 9.5ML TO NATURALLY BACKFLOW INTO THE SYRINGE. THEN PULLED BACK WITH THE SYRINGE TO DOUBLE-CHECK IF THERE WAS ANY MORE AIR OR WATER LEFT IN THE BALLOON. PULLED BACK 2 ADDITIONAL TIMES TO VERIFY THERE WAS NOTHING LEFT IN THE BALLOON. CATHETER PULLED OUT WITH NO RESISTANCE. WHEN IT WAS COMPLETELY OUT, THERE WAS STILL A TINY AMOUNT OF AIR INFLATED IN THE BALLOON. PT BLED FROM HIS URETHRA FOR A FEW MINUTES AFTERWARDS AND THEN RESOLVED. 3. REMOVING THE PATIENT'S CATHETER- WITHDREW ALL 10ML OF SALINE, GOT A SECOND SYRINGE, AND DOUBLE-CHECKED THAT I REMOVED IT ALL, THEN PULLED IT. UPON REMOVAL, THERE WAS STILL A SMALL AMOUNT OF SALINE AND/OR AIR LEFT, CAUSING DISCOMFORT TO THE PATIENT AND ULTIMATELY A SMALL AMOUNT OF BLEEDING FROM THE URETHRA.