BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGB+

    MDR report key: 3658347 · Received February 26, 2014

    Report

    Report Number
    MW5034763
    Event Type
    Injury
    Date Received
    February 26, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 25, 2014
    Manufacturer
    ARROW
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING INSERTION OF SUBCLAVIAN CVC, THE INTRODUCER NEEDLE BROKE OFF OF THE HUB OF THE SYRINGE, AND IS NOW RETAINED INSIDE OF PATIENT. PATIENT IS A (B)(6) YEAR OLD MALE WHO UNDERWENT AN EMERGENT VENTRAL HERNIA REPAIR DUE TO THE HERNIA CONTAINING THE TRANSFERS COLON AND CONCERN FOR INCARCERATION. POST-OP, REMAINED IN THE ICU INTUBATED AND SEDATED. DIAGNOSIS OR REASON FOR USE: PT CRITICALLY ILL AND NEEDED CVC PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118686 AGB+ MULTI-LUMEN CVC KIT DQY ARROW 23F14A0539

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| R