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)
Manufacturer
Medline Industries, Inc.Model number
URO175816Catalog 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.