BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXT CLEARVIEW

    MDR report key: 1210145 · Received September 20, 2007

    Report

    Report Number
    1210145
    Event Type
    Malfunction
    Date Received
    September 20, 2007
    Date of Event
    February 20, 2007
    Report Date
    April 13, 2007
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    POSSIBLE PART MISSING IN PACKAGING OF AN INSERTED CENTRAL VENOUS CATHETER. AFTER ONE OF OUR NURSES INSERTED A PICC, IT WAS DISCOVERED THAT A GRAY ATTACHMENT CAPPING DEVICE WAS APPARENTLY MISSING FROM THE KIT. CUSTOMER SERVICE WAS CONTACTED AND THE CATHETER HAD TO BE REMOVED. WE SUSPECT THE PART WAS MISSING FROM THE KIT; HOWEVER, WE CAN'T BE SURE BECAUSE THE NURSE DID NOT CHECK ALL THE PARTS OF THE KIT PRIOR TO THE INSERTION OF THE PICC. THERE WAS NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXT CLEARVIEW CATHETER, PICC LJS BARD ACCESS SYSTEMS * REQH0329

    Patients

    Seq Age Sex Outcome Treatment
    1 *