inforMED
MalfunctionPPB

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)

Model number

URO175216

Lot 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.