BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY

    MDR report key: 9194251 · Received October 15, 2019

    Report

    Report Number
    1018233-2019-06504
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Report Date
    October 25, 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
    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: URO-PREP¿ TRAY WITH: UNDERPAD, DRAPE POVIDONE-IODINE SOLUTION NPN 02076144 10CC SYRINGE (PREFILLED WITH STERILE WATER) TO INFLATE FOLEY CATHETER ONLY. STERILE: CONTENTS OF INNER WRAP ARE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. DIRECTIONS FOR USE ON REVERSE SIDE. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. LATEX-FREE, POWDER-FREE GLOVES(2) SPECIMEN CONTAINER AND LABEL LUBRICANT PACKET, FORCEPS, PREP BALLS (5) GRADUATED COLLECTION CONTAINER" 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 THAT THE IODINE WAS MISSING FROM THE KIT. NO MEDICAL INTERVENTION WAS REQUIRED.

    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 IODINE WAS MISSING FROM THE KIT. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983896 BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY SURESTEP FOLEY KIT KNX C.R. BARD, INC. (COVINGTON) -1018233 782100 UNK 00801741029622

    Patients

    Seq Age Sex Outcome Treatment
    1