BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY

    MDR report key: 8271048 · Received January 23, 2019

    Report

    Report Number
    1018233-2019-00383
    Event Type
    Malfunction
    Date Received
    January 23, 2019
    Report Date
    February 20, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741029622
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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 WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. 1. OPEN CSR WRAP TO FORM STERILE FIELD. 2. PLACE UNDERPAD BENEATH PATIENT, PLASTIC SIDE DOWN. 3. PUT ON CUFFED GLOVES. 4. POSITION DRAPE ON PATIENT. 5. REMOVE TOP TRAY. 6. OPEN LUBRICANT. LUBRICATE CATHETER. 7. POUR CLEANSING SOLUTION ONTO PREP BALLS. 8. PREP PATIENT WITH SATURATED PREP BALLS. 9. PROCEED WITH CATHETERIZATION IN USUAL MANNER. 10. IF SPECIMEN IS REQUIRED, FILL STERILE CONTAINER FROM CATHETER. 11. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. 12. IF URINE IS PLACED IN SPECIMEN JAR: A. SECURE CAP. B. LABEL SPECIMEN JAR. C. SEND SPECIMEN TO LABORATORY. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTED MEDICAL PRACTICE AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP TRAY IN PLACE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 10CC STERILE WATER SYRINGE WAS MISSING FROM THE TRAY.

    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 10CC STERILE WATER SYRINGE WAS MISSING FROM THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65698 BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY FOLEY TRAY KNX C.R. BARD, INC. (COVINGTON) -1018233 782100 UNK 00801741029622

    Patients

    Seq Age Sex Outcome Treatment
    1