MalfunctionPPB
TOTAL ONE LAYER TRAY SELECT SILICONE
Received Mar 16, 2026 · Event occurred Mar 9, 2026
Report MW5185375 · MDR key 24619104
Device
Generic name
Foley Catheter Kit (excludes Hiv Testing)
Manufacturer
Medline Industries, Lp - SptLot number
(10) 25JBR270
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING CATHETER SET UP IT WAS NOTED THAT THIS KIT DID NOT CONTAIN POVIDONE IODINE SWAB STICK. KIT WAS DISCARDED AND ANOTHER TRAY WAS USED. NO PATIENT HARM. TOTAL ONE LAYER TRAY SELECT SILICONE TEMPERATURE SENSING CLOSED SYSTEM WITH 100% SILICONE TEMPERATURE SENSING FOLEY CATHETER PRE-CONNECTED TO 400 ML METAL FREE URINE METER AND 2500 ML DRAINAGE BAG. PRODUCT INFO (10) 25JBR270, EXP 07/31/2027, GTIN: (B)(4).