BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOSTAR CENTRAL VENOUS CATHETER

    MDR report key: 2640440 · Received June 27, 2012

    Report

    Report Number
    1056436-2012-00047
    Event Type
    Other
    Date Received
    June 27, 2012
    Date of Event
    June 21, 2012
    Report Date
    June 27, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQO
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT WAS BROUGHT IN WITH EXISTING NEO-STAR, THE CATH WAS FOUND TO BE LEAKING ALTHOUGH A HOLE CANNOT BE FOUND AT THIS TIME. THE PT WAS TAKEN TO SPECIAL PROCEDURES TO HAVE THE PRODUCT REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOSTAR CENTRAL VENOUS CATHETER CHRONIC CVC CATHETER DQO ANGIODYNAMICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1