BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC 3 GO MALE COUDE CATHETER

    MDR report key: 7969487 · Received October 16, 2018

    Report

    Report Number
    1018233-2018-04765
    Event Type
    Malfunction
    Date Received
    October 16, 2018
    Report Date
    December 20, 2018
    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
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. VISUAL EVALUATION NOTED 5 UNOPENED SAMPLES IN ORIGINAL PACKAGING. NO DAMAGE WAS NOTED ON THE EXTERIOR OF THE PACKAGING. DIP LINE AND HYDROPHILIC COATING PRESENT. COEFFICIENT OF FRICTION WAS PERFORMED. EACH SAMPLE WAS CUT IN HALF IN ORDER TO TEST AS A PAIR. KINETIC COF WAS FOUND (.041, .067) TO BE WITHIN SPECIFICATION ( <0.400) FOR ALL CATHETERS TESTED. 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: "PLEASE READ ALL INSTRUCTIONS BEFORE USING THIS DEVICE. CAUTION: FEDERAL (USA) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. DEVICE DESCRIPTION: THE MAGIC3 GO® INTERMITTENT URINARY CATHETER IS A SILICONE TUBE INSERTED INTO THE URETHRA FOR THE PURPOSE OF DRAINING THE BLADDER OF URINE. NOT MADE WITH NATURAL RUBBER LATEX DOES NOT CONTAIN DEHP INDICATIONS FOR USE: THE MAGIC3 GO® INTERMITTENT URINARY CATHETER IS INTENDED FOR UROLOGICAL USE ONLY. IT IS INTENDED FOR USE BY ADULT AND PEDIATRIC PATIENTS OF ALL AGES FOR BLADDER MANAGEMENT INCLUDING URINE DRAINAGE, COLLECTION, AND MEASUREMENT. THE DEVICE IS PASSED TO THE URINARY BLADDER VIA THE URETHRA. CONTRAINDICATIONS NONE KNOWN. WARNINGS: THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. PRECAUTIONS INSPECT THE CATHETER BEFORE USE. DO NOT USE THE PRODUCT IF THE DEVICE OR PACKAGING IS DAMAGED. SELF-CATHETERIZATION SHOULD FOLLOW THE PLAN OF CARE AND ADVICE GIVEN BY YOUR HEALTHCARE PRACTITIONER AND BE CARRIED OUT ONLY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE PROVIDED. PLEASE CONSULT YOUR HEALTHCARE PRACTITIONER IF ANY CONDITIONS OCCUR WHICH CREATE CONCERN AND/OR DIFFICULTY DURING CATHETERIZATION. ADVERSE REACTIONS URINARY TRACT INFECTION BLEEDING FROM THE URETHRA IRRITATION OF THE URETHRA."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS NOT LUBRICATED ENOUGH.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS NOT LUBRICATED ENOUGH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810799 MAGIC 3 GO MALE COUDE CATHETER MAGIC 3 CATHETER EZD C.R. BARD, INC. (COVINGTON) -1018233 JUCS0098 00801741137020

    Patients

    Seq Age Sex Outcome Treatment
    1