FOLEY TOTAL ONE LAYER TRAY
Received Mar 5, 2026 · Event occurred Feb 26, 2026
Report MW5184770 · MDR key 24520098
Device
Generic name
Foley Catheter Kit (excludes Hiv Testing)
Manufacturer
Medline Industries, Lp - SptModel number
URO175216Lot number
(10) 25HBS747
Patient
81 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
INSTALLATION PORT ON THE SIDE OF THE FOLEY DRAINAGE TUBE DISCONNECTS WHEN APPLYING EQUASHIELD. THIS RESULTS IN THE NEED TO DETACH THE DRAINAGE BAG FROM THE FOLEY AND REATTACH A NEW DRAINAGE BAG BEFORE PROCEEDING WITH INSTALLATION OF CHEMO INTO THE BLADDER. IN THIS CASE, THE RN FELT IT GIVE A LITTLE, SO SHE WAS CAUTIOUS IN MAINTAINING CONNECTIONS AS SHE PROCEEDED TO INSTILL THE MEDICATION INTO THE BLADDER, THEN CAREFULLY REMOVED THE EQUASHIELD AND TAPED THE CONNECTION TO BE SURE IT REMAINED SECURE. RN STATES THAT SHE HAD THE PORT BECOME DISCONNECTED.