BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 8196997 · Received December 26, 2018

    Report

    Report Number
    1018233-2018-06161
    Event Type
    Malfunction
    Date Received
    December 26, 2018
    Report Date
    January 21, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030413
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: ¿SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. CONTENTS OF INNER WRAP ARE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. 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. 7. PREP PATIENT WITH POVIDONE-IODINE SWABSTICKS. 8. PROCEED WITH CATHETERIZATION IN USUAL MANNER. 9. IF SPECIMEN IS REQUIRED, FILL STERILE CONTAINER FROM CATHETER. 10. TOP TRAY MAY BE PLACED ON BASIN TO HELP PREVENT SPILLAGE. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2010 C. R. BARD, INC. ALL RIGHTS RESERVED. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP¿ TRAY IN PLACE. 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. 11. IF URINE IS PLACED IN SPECIMEN JAR: A. SECURE CAP. B. LABEL SPECIMEN JAR. C. SEND SPECIMEN TO LABORATORY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER 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 CATHETER WAS MISSING FROM THE TRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1036897 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER URETHRAL CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772415 UNK 00801741030413

    Patients

    Seq Age Sex Outcome Treatment
    1