BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGIC3 GO MALE COUDE CATHETER WITH SUREGRIP

    MDR report key: 15650024 · Received October 21, 2022

    Report

    Report Number
    1018233-2022-08052
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 30, 2022
    Report Date
    November 17, 2022
    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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE. NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "OUTSIDE DIAMETER IS TOO LARGE ROUGH OR IRREGULAR SHAPE PROTRUSIONS". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "INDICATIONS FOR USE THE MAGIC 3 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, 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. " H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME OF THE INTERMITTENT CATHETERS SENT WOULD NOT PROPERLY INSERT. THE REPRESENTATIVE TOLD IT COULD BE BECAUSE THE PATIENT WAS USING THE COUDE TIP CATHETERS AND MIGHT NEED STRAIGHT TIP CATHETERS, BUT THE PATIENT DID NOT THINK SO. REPRESENTATIVE OFFERED TO SEND SAMPLES OF OTHER COUDE TIP CATHETERS PRE LUBRICATED BEFORE PLACING REORDER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SOME OF THE INTERMITTENT CATHETERS SENT WOULD NOT PROPERLY INSERT. THE REPRESENTATIVE TOLD IT COULD BE BECAUSE THE PATIENT WAS USING THE COUDE TIP CATHETERS AND MIGHT NEED STRAIGHT TIP CATHETERS, BUT THE PATIENT DID NOT THINK SO. REPRESENTATIVE OFFERED TO SEND SAMPLES OF OTHER COUDE TIP CATHETERS PRE LUBRICATED BEFORE PLACING REORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1927771 MAGIC3 GO MALE COUDE CATHETER WITH SUREGRIP INTERMITTENT CATHETER EZD C.R. BARD, INC. (COVINGTON) -1018233 50814G UNK 00801741137020

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other