Description of Event or Problem · 1
PATIENT IS A (B)(6) MALE WITH AN INDWELLING URINARY CATHETER SINCE (B)(6) 2021. PATIENT USES A STATLOCK CATHETER STABILIZATION DEVICE (MANUFACTURER C. R. BARD, INC. (B)(4)) WHICH HE RECEIVES FROM HIS UROLOGIST. PATIENT HAD CATHETER CHANGED AT UROLOGY CLINIC ON (B)(6) 2021 WITH NO ISSUES AND RECEIVED THE CUSTOMARY STATLOCK SUPPLIES TO USE UNTIL HIS NEXT CATHETER CHANGE. I AM HIS DAUGHTER AND HAVE BEEN CARING FOR HIM SINCE (B)(6) 2021 AND AM THE REPORTER. TO DATE, WE HAVE HAD NO ISSUES WITH THE STATLOCK HOLDING THE CATHETER IN PLACE; HOWEVER, I HAVE HAD TO REPLACE ALL STATLOCK SUPPLIES RECEIVED SINCE THE CATHETER CHANGE DUE TO THE CATHETER HOLDER LOCKING DEVICE NOT STAYING CLOSED. THREE OF THE FOUR LOCKING DEVICES HAVE OPENED ON THEIR OWN (THIS HAS NOT HAPPENED BEFORE). THE DEVICE CLICKS TO THE CLOSED POSITION, APPEARS TO BE SECURED AND THEN WHEN I CHECK, THE LOCK HAS OPENED. THE PATIENT IS PRIMARILY SEDENTARY. TO KEEP THE CATHETER IN PLACE I HAVE USED ELASTIC BANDAGE WRAP AND CLOTH TAPE TO HOLD THE LOCKING DEVICE IN PLACE TO PREVENT INADVERTENT INJURY. THE PRODUCT NUMBER IS FOL0101 AND THE LOT/USE BY DATE OF THE DEVICES USED THIS WEEK THAT I HAVE RETAINED ARE: JUDY2781/2022-11-28, JUFP8111/2024-01-28, JUFP8026/2024-01-28. I HAVE THE DEFECTIVE DEVICES, BUT CANNOT ATTRIBUTE WHICH LOT WAS USED THAT WAS DEFECTIVE. FDA SAFETY REPORT ID # (B)(4).