BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER

    MDR report key: 8815855 · Received July 23, 2019

    Report

    Report Number
    1018233-2019-04139
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Report Date
    August 12, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030406
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: ¿CONTENTS: ** RED RUBBER CATHETER, 15 FR., PRECONNECTED TO CLOSED SYSTEM COLLECTION BAG (1000ML APPROX. VOL.) URO-PREP¿ TRAY WITH: UNDERPAD, DRAPE POVIDONE-IODINE SWABSTICKS (3) SPECIMEN CONTAINER AND LABEL GRADUATED COLLECTION CONTAINER SYNTHETIC VINYL GLOVES (2) LUBRICANT PACKET STERILE: CONTENTS OF INNER WRAP ARE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED." H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE PATIENTS CAREGIVER THAT THE TRAY WAS MISSING THE BZK SWABSTICKS AND 5G LUBRICATING JELLY. THIS WAS NOTED PRIOR TO USE.

    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 BY THE PATIENTS CAREGIVER THAT THE TRAY WAS MISSING THE BZK SWABSTICKS AND 5G LUBRICATING JELLY. THIS WAS NOTED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612932 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER 15 FR CATHETER TRAY KOD C.R. BARD, INC. (COVINGTON) -1018233 772414 UNK 00801741030406

    Patients

    Seq Age Sex Outcome Treatment
    1