BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 7852512 · Received September 6, 2018

    Report

    Report Number
    1018233-2018-04031
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Report Date
    October 2, 2018
    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
    GA, 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: "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. DIRECTIONS FOR USE: 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. 11. IF URINE IS PLACED IN SPECIMEN JAR: A. SECURE CAP. B. LABEL SPECIMEN JAR. C. SEND SPECIMEN TO LABORATORY. VOLUME ON COLLECTION CONTAINER HAS BEEN CALIBRATED WITHOUT URO-PREP¿ TRAY IN PLACE. BARD AND URO-PREP ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. ©2010 C. R. BARD, INC. ALL RIGHTS RESERVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CATHETER WAS INSERTED NOT MUCH/NO URINE DRAINED AND THE PATIENT LATER HAD A VERY LARGE RESERVE OF URINE.

    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. THE DEVICE WAS NOT RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CATHETER WAS INSERTED NOT MUCH/NO URINE DRAINED AND THE PATIENT LATER HAD A VERY LARGE RESERVE OF URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691921 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772415 UNK 00801741030413

    Patients

    Seq Age Sex Outcome Treatment
    1