BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER

    MDR report key: 8026183 · Received October 31, 2018

    Report

    Report Number
    1018233-2018-05104
    Event Type
    Malfunction
    Date Received
    October 31, 2018
    Report Date
    December 7, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741030437
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "CONTENTS: VINYL CATHETER, 14 FR. URO-PREP¿ TRAY WITH: UNDERPAD, DRAPE POVIDONE-IODINE SWABSTICKS (3) SPECIMEN CONTAINER AND LABEL C. R. BARD, INC. COVINGTON, GA 30014 1-800-526-4455 WWW.BARDMEDICAL.COM MANUFACTURED IN MEXICO LATEX-FREE GLOVES (2) LUBRICANT GRADUATED COLLECTION CONTAINER PK7631570 08/2010 BARD ® URETHRAL CATHETERIZATION TRAY 772417 VINYL CATHETER PATIENT¿S NAME ROOM NUMBER ADM. NO. DATE VINYL CATHETER 14 FR. DIRECTIONS FOR USE ON REVERSE SIDE. SINGLE USE ONLY. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. STERILE: CONTENTS OF INNER WRAP ARE STERILE UNLESS PACKAGE IS OPENED OR DAMAGED"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A MISSING CATHETER AND RAYON BALLS FROM THE CATHETER TRAY PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A MISSING CATHETER AND RAYON BALLS FROM THE CATHETER TRAY PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862823 BARD® URETHRAL CATHETERIZATION TRAY WITH VINYL CATHETER CATHETER KIT KOD C.R. BARD, INC. (COVINGTON) -1018233 772417 NGCR0166 00801741030437

    Patients

    Seq Age Sex Outcome Treatment
    1