BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAGIC3 GO¿ INTERMITTENT URINARY CATHETER

    MDR report key: 7743930 · Received August 2, 2018

    Report

    Report Number
    1018233-2018-03260
    Event Type
    Injury
    Date Received
    August 2, 2018
    Report Date
    September 6, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZD
    UDI-DI
    00801741097898
    PMA / PMN Number
    K150345
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "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 FEMALE PATIENTS 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. ADVERSE REACTIONS URINARY TRACT INFECTION BLEEDING FROM THE URETHRA IRRITATION OF THE URETHRA INSTRUCTIONS FOR USE 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." CORRECTION: MFR SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED AN URINARY TRACT INFECTION WHILE USING THE MAGIC 3 CATHETERS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND IN ADDITION TO OVER-THE-COUNTER AZO MEDICATION.

    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 BARD 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 BARD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A URINARY TRACT INFECTION WHILE USING THE MAGIC 3 CATHETERS. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND IN ADDITION TO OVER-THE-COUNTER AZO MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583578 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER MAGIC 3 CATHETER EZD C.R. BARD, INC. (COVINGTON) -1018233 51814 UNK 00801741097898

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention