BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW BLUE PLUS PRESSURE INJECTABLE TRIPLE-LUMEN CVC

    MDR report key: 1810675 · Received August 16, 2010

    Report

    Report Number
    MW5017118
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ARROW/TELEFLEX MEDICAL
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MD PLACING LEFT SUBCLAVIAN CENTRAL LINE AND NEEDLE BROKE OFF INTO PT'S LUNG. DATES OF USE: (B)(6) 2010 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: NEED FOR CENTRAL LINE FOR MULTIPLE DRUG THERAPIES. EVENT ABATED AFTER USE: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROW BLUE PLUS PRESSURE INJECTABLE TRIPLE-LUMEN CVC TRIPLE LUMEN CATHETER FOZ ARROW/TELEFLEX MEDICAL RF 0047057

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR