SURESTEP FOLEY TRAY SYSTEM 16 FR
Received Jun 9, 2022 · Event occurred May 24, 2022
Report MW5110228 · MDR key 14653404
Device
Generic name
Catheter, Urological (antimicrobial) And Accessories
Manufacturer
Bard Sdn., Bhd.Model number
A947316Lot number
NGGP3777
Product problems
- Difficult to Remove
- Material Deformation
- Physical Resistance/Sticking
Patient
63 YR · Male
- Hemorrhage/Blood Loss/Bleeding
- Pain
- Hemorrhage/Blood Loss/Bleeding
- Pain
Narrative
Description of Event or Problem
IN PROCESS OF DISCONTINUING FOLEY CATHETER AND NOTICED MUCH RESISTANCE EVEN THOUGH FULL 10 ML "NS" REMOVED FROM BALLOON. TRIED TO REMOVE MORE INCASE OVER FILLED. MUCH RESISTANCE PROVIDED PAIN AND SLIGHT BLOODY DRAINAGE FROM PT'S URETHRA. UPON REMOVAL NOTICED DEFORMITY OF CATHETER TUBING IN THE TIP WHERE THE BALLOON WAS RIDGED AND DIAMETER THICKNESS SIGNIFICANTLY MORE THAT THE REST OF TUBING CAUSING RESISTANCE WHEN ATTEMPTING TO SMOOTHLY REMOVE TUBING FROM URETHRA, SUSPECT MINOR URETHRAL TRAUMA DUE TO VISIBLE BLOODY DRAINAGE. SAMPLE SAVED PT'S NURSE AND NURSING SUPERVISOR MADE AWARE.