BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS

    MDR report key: 2993979 · Received February 27, 2013

    Report

    Report Number
    MW5029221
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAD A DOUBLE LUMEN ANGIODYNAMIC PICC LINE. NURSE CONTACTED PICC NURSE STATING PICC LINE WAS LEAKING AND CRACKED. UPON ASSESSMENT, PICC NURSE FOUND PICC LINE TO BE FRACTURED AT THE BLUE HUB SITE. PICC LINE WAS DISCONTINUED TO AVOID INFECTION OR POSSIBLE AIR EMBOLISM AND NEW ACCESS WAS OBTAINED. DATES OF USE: (B)(6) 2013. DIAGNOSIS OR REASON FOR USE: PT NEEDED LONG TERM IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84429 ANGIODYNAMICS MORPHEUS SMART PICC CT WITH STYLET LJS ANGIODYNAMICS, INC 581469

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention