BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3 GO 14 FR MALE COUDE CATHETER WITH SUREGRIP

    MDR report key: 7891952 · Received September 19, 2018

    Report

    Report Number
    1018233-2018-04284
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Report Date
    December 17, 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
    CT, 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 EXTERIOR OF THE PACKAGING. DIP LINE AND HYDROPHILIC COATING WAS PRESENT. COEFFICIENT OF FRICTION WAS PERFORMED. EACH SAMPLE WAS CUT IN HALF IN ORDER TO TEST AS A PAIR. KINETIC COF WAS FOUND (.032, .045) 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 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." SECTION A THROUGH F - 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LACKED LUBRICITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729399 MAGIC3 GO 14 FR MALE COUDE CATHETER WITH SUREGRIP MAGIC 3 CATHETER EZD C.R. BARD, INC. (COVINGTON) -1018233 JUCT0173 00801741137020

    Patients

    Seq Age Sex Outcome Treatment
    1