BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURE MEDICAL CATHETER INSERTION KIT

    MDR report key: 8384561 · Received March 2, 2019

    Report

    Report Number
    3005471919-2019-00016
    Event Type
    Injury
    Date Received
    March 2, 2019
    Date of Event
    December 31, 2018
    Report Date
    March 1, 2019
    Manufacturer
    CURE MEDICAL LLC
    Product Code
    OHR
    UDI-DI
    00815947020468
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER'S TECHNIQUE WAS REVIEWED AND IT WAS FOUND THAT HE WAS HANDLING AN ALCOHOL PREP PAD (MANUFACTURED BY (B)(4)) THAT IS NOT PART OF THE STERILE INSERTION KIT. THE USER WAS USING THE BZK SWAB SUPPLIED WITH THE KIT AND THE ALCOHOL PREP PAD TO WIPE DOWN THE GLOVES. THE RECOMMENDED TECHNIQUE DOES NOT CALL FOR USING A SEPARATE ALCOHOL PREP PAD. THE BZK SWAB SUPPLIED IN THE STERILE INSERTION KIT IS MEANT TO BE USED TO CLEAN THE URETHRAL OPENING AND NOT THE GLOVES. IT IS UNCLEAR WHY THE USER WAS USING THE ALTERNATE TECHNIQUE AND HE WAS ADVISED TO DISCUSS HIS CATHETERIZATION TECHNIQUE WITH HIS DOCTOR AS IT APPEARS TO DEVIATE FROM ACCEPTED CLINICAL PRACTICE. HANDLING OF THE ALCOHOL PREP PAD (PACKAGING IS NOT STERILE) DURING THE INSERTION PROCESS MAY LEAD TO CONTAMINATION OF THE GLOVES WHICH ARE LATER USED TO INSERT THE CATHETER. THIS REPORT IS MADE FOR THE INSERTION KIT AND A SEPARATE REPORT IS MADE FOR THE CATHETER SINCE IT CANNOT BE DETERMINED THE EXTENT TO WHICH EITHER DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.

    Description of Event or Problem · 1

    ROUTINE INTERMITTENT CATHETER PATIENT (USER) ACQUIRED A UTI WHILE CONCURRENTLY USING BOTH A CURE MEDICAL BRAND INTERMITTENT CATHETER AND CATHETER INSERTION KIT (GLOVES, BZK WIPE, COLLECTION BAG, UNDERPAD, LUBRICATING JELLY). NO SPECIFIC PROBLEMS WERE REPORTED WITH THE CATHETER OR INSERTION KIT BUT THE USER STATED HE HAD DIFFICULTY INSERTING THE CATHETER. THE USER ALSO REPORTED HE WAS NOT FOLLOWING THE RECOMMENDED TECHNIQUE WHICH MAY INTRODUCE CONTAMINATION THAT COULD CAUSE OR CONTRIBUTE TO AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177822 CURE MEDICAL CATHETER INSERTION KIT CATHETER CARE TRAY OHR CURE MEDICAL LLC K1 17B15702 00815947020468

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other