BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3¿ INTERMITTENT CATHETER

    MDR report key: 8921852 · Received August 22, 2019

    Report

    Report Number
    1018233-2019-04988
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Report Date
    August 22, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZD
    UDI-DI
    00801741136962
    PMA / PMN Number
    K172247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE OF THIS FAILURE MODE COULD BE "OPERATOR ERROR - VISCOMETER OOC - VISCOMETER FAILURE - MECHANICAL FAILURE". THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "REVIEW THE SELF-CATHETERIZATION PROCEDURE WITH A HEALTHCARE PROFESSIONAL. 1. ALWAYS WASH HANDS PRIOR TO USE. 2. OPEN THE CATHETER PACKAGE BY PEELING THE TAB UPWARDS WITH THE AID OF THE FINGER HOLE. 3. IF DESIRED, USE THE ADHESIVE LABEL(S) TO HANG THE PACKAGE ON A NEARBY DRY VERTICAL SURFACE WHILE PREPARING TO CATHETERIZE. 4. CLEAN THE OPENING TO THE URETHRA ¿ AND THE SURROUNDING AREA. WIPE FROM FRONT TO BACK TO AVOID FECAL CONTAMINATION. WASH YOUR HANDS AGAIN. 5. HOLD THE INSERTION SLEEVE WITH YOUR DOMINANT HAND AND SQUEEZE IT TO GRIP THE CATHETER SHAFT AS YOU REMOVE THE CATHETER FROM THE PACK. NEXT, HOLD THE CATHETER FUNNEL ABOVE THE INSERTION SLEEVE WITH YOUR OTHER HAND AND SLIDE THE INSERTION SLEEVE DOWN THE SHAFT, STOPPING AT ABOUT 6¿ FROM THE TIP. RELEASE THE FUNNEL. USING THE INSERTION SLEEVE TO HOLD THE CATHETER FIRMLY, GENTLY PASS THE TIP OF THE CATHETER INTO YOUR URETHRA UNTIL THE INSERTION SLEEVE NEARS THE MEATUS. REPEAT UNTIL URINE STARTS TO FLOW. 6. KEEP THE CATHETER STEADY UNTIL URINE STOPS FLOWING. WHEN URINE STOPS FLOWING, SLOWLY WITHDRAW THE CATHETER, STOPPING IF FLOW STARTS AGAIN, UNTIL THE LAST FEW DROPS HAVE DRAINED. CHECK THE COLOR, ODOR AND CLARITY OF THE URINE. ANY CHANGES MAY NEED TO BE REPORTED TO A HEALTH CARE PROFESSIONAL. DISPOSAL 7. PLACE THE CATHETER BACK INTO THE PACKAGE AND DISPOSE IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. DO NOT FLUSH DOWN THE TOILET. 8. WASH HANDS."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAGIC 3 CATHETER WAS DRY. THE PATIENT BELIEVED HE DEVELOPED A STRICTURE POSSIBLY DUE TO THE USE OF THE CATHETER. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715162 MAGIC3¿ INTERMITTENT CATHETER MAGIC 3 GO MALE CATHETER EZD C.R. BARD, INC. (COVINGTON) -1018233 53814G UNK 00801741136962

    Patients

    Seq Age Sex Outcome Treatment
    1