BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3 GO¿ INTERMITTENT URINARY CATHETER

    MDR report key: 8732734 · Received June 25, 2019

    Report

    Report Number
    1018233-2019-03364
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Report Date
    July 19, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZD
    UDI-DI
    00801741097898
    PMA / PMN Number
    K150345
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT COULD NOT BE CONFIRMED. NO SAMPLE WAS 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, HANG THE PACKAGE WITH THE ADHESIVE SURFACE ON THE INNER SIDE OF THE TAB TO A NEARBY DRY VERTICAL SURFACE WHILE PREPARING TO CATHETERIZE. 4. POSITIONED COMFORTABLY WITH THIGHS SPREAD APART, CLEAN THE OPENING TO THE URETHRA ¿ AND THE SURROUNDING AREA. WIPE FROM FRONT TO BACK TO AVOID FECAL CONTAMINATION. WASH YOUR HANDS AGAIN. 5. REMOVE THE CATHETER WITH THE AID OF THE INSERTION HANDLE AND ADVANCE THE CATHETER TIP INTO THE URETHRA. SLOWLY AND GENTLY INSERT THE CATHETER INTO THE URETHRA UNTIL URINE BEGINS TO FLOW (APPROXIMATELY 1-1.5" OR 2.5-3.8 CM). 6. WHEN URINE STOPS FLOWING, BEGIN TO WITHDRAW THE CATHETER. IT IS RECOMMENDED TO SLOWLY ROTATE THE CATHETER DURING WITHDRAWAL, STOPPING EACH TIME URINE BEGINS TO FLOW. 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 · 0

    IT WAS REPORTED THAT THE MAGIC 3 CATHETERS LACKED LUBRICITY. THE PATIENT WAS ABLE TO VOID. NO MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MAGIC 3 CATHETERS LACKED LUBRICITY. THE PATIENT WAS ABLE TO VOID. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526183 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER MAGIC 3 GO INTERMITTENT CATHETER EZD C.R. BARD, INC. (COVINGTON) -1018233 51814 UNK 00801741097898

    Patients

    Seq Age Sex Outcome Treatment
    1