BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY

    MDR report key: 8340448 · Received February 14, 2019

    Report

    Report Number
    1018233-2019-00798
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Report Date
    March 22, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. LATEX-FREE, POWDER-FREE GLOVES(2) SPECIMEN CONTAINER AND LABEL LUBRICANT PACKET, FORCEPS, PREP BALLS (5) GRADUATED COLLECTION CONTAINER"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE WATER SYRINGE FROM THE FOLEY CATHETER TRAY WAS EMPTY. THE TRAY WAS STILL USED WITH SALINE INSTEAD OF WATER.

    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 WATER SYRINGE FROM THE FOLEY CATHETER TRAY WAS EMPTY. THE TRAY WAS STILL USED WITH SALINE INSTEAD OF WATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131332 BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY FOLEY CATHETER TRAY KNX C.R. BARD, INC. (COVINGTON) -1018233 782100 UNK 00801741029622

    Patients

    Seq Age Sex Outcome Treatment
    1