inforMED
MalfunctionPPB

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)

Model number

URO175816T

Catalog 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.