BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3 GO¿ INTERMITTENT URINARY CATHETER

    MDR report key: 9361733 · Received November 22, 2019

    Report

    Report Number
    1018233-2019-07483
    Event Type
    Malfunction
    Date Received
    November 22, 2019
    Report Date
    December 9, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZD
    UDI-DI
    00801741137020
    PMA / PMN Number
    K172247
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿TOO HIGH VISCOSITY¿. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "VISCOMETER OOC". THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. 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 · 0

    IT WAS REPORTED THAT THE PATIENT SAID SOME OF THE CATHETERS IN THE BATCH WERE REALLY STICKY, AND MADE IT DIFFICULT TO USE. THE PATIENT SAID THEY WERE EXTREMELY UNCOMFORTABLE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAID SOME OF THE CATHETERS IN THE BATCH WERE REALLY STICKY, AND MADE IT DIFFICULT TO USE. THE PATIENT SAID THEY WERE EXTREMELY UNCOMFORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1161175 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER MAGIC 3 MALE GO EZD C.R. BARD, INC. (COVINGTON) -1018233 50814G JUCZ0044 00801741137020

    Patients

    Seq Age Sex Outcome Treatment
    1