MEDLINE INDUSTRIES, INC.
Received Jun 23, 2026 · Event occurred Jun 10, 2026
Report 25592525 · MDR key 25592525
Device
Generic name
Foley Catheter Kit (excludes Hiv Testing)
Manufacturer
Medline Industries, Inc.Model number
URO175816TCatalog number
URO175816T
Lot number
26CBR841
Patient
58 YR · Male
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
CRNA IN ROOM NOTICES DECREASED URINE OUTPUT FROM URINARY CATHETER. CRNA ALSO NOTICES BLOOD TINGING OF THE LITTLE AMOUNT IN THE URINARY CATHETER TUBING. SURGEON MADE AWARE. RESIDENT ASSESSES THE INSERTION. RESIDENT FINDS THAT THE URINARY CATHETER IS REMOVED WITH THE BALLOON DEFLATED. RN ASSESSES THE BALLOON WITH A NORMAL SALINE FLUSH AND TEAM ESTABLISHES THAT THE BALLOON HAS A PIERCING. RESIDENT ASSIGNED APPARENTLY USED 2 OTHER FOLEYS FOR THE SAME PATIENT AND HAD THE SAME BALLOON DEFECT ISSUE. ALL FOLEY KITS HAVE THE SAME LOT NUMBER, PROMPTING THE REMOVAL OF THE KITS FROM OUR MAIN SUPPLY ROOM BY OUR SUPPLIES MANAGER. MANUFACTURER RESPONSE FOR URINARY CATHETER, (BRAND NOT PROVIDED) (PER SITE REPORTER) MEDLINE NOTIFIED 06/15/26, ASKED ADDITIONAL QUESTIONS.