BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® UNIVERSAL CATHETERIZATION TRAY

    MDR report key: 8342688 · Received February 15, 2019

    Report

    Report Number
    1018233-2019-00805
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Report Date
    May 16, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    OHR
    UDI-DI
    00801741029646
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE DUE TO A POOR SAMPLE CONDITION, AND SINCE THERE WAS NOT ENOUGH INFORMATION TO CONFIRM THAT THE TRAY WAS RECEIVED WITHIN A BOX OF 770715. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE UNOPENED LATEX INTERMITTENT CATHETER TRAY WITH THE PRODUCT CATALOG NUMBER 792100 AND LOT NUMBER NGCW3098. IT WAS NOTED THAT THE OUTER CASE WITH THE LABELING OF THE 770715 TRAY AND 770715 TRAYS WITHIN THE CASE WERE NOT RETURNED. 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: ¿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 LUBRICATION-LUBRICATE CATHETER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER TRAY (792100) WAS IN A CASE OF INTERMITTENT CATHETER TRAYS (770715).

    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 TRAY (792100) WAS IN A CASE OF INTERMITTENT CATHETER TRAYS (770715).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139297 BARD® UNIVERSAL CATHETERIZATION TRAY TRAY OHR C.R. BARD, INC. (COVINGTON) -1018233 792100 NGCW3098 00801741029646

    Patients

    Seq Age Sex Outcome Treatment
    1