BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SKLAR STERILE

    MDR report key: 602347 · Received May 11, 2005

    Report

    Report Number
    MW1035432
    Event Type
    Malfunction
    Date Received
    May 11, 2005
    Date of Event
    April 27, 2005
    Manufacturer
    SKLAR INSTRUMENTS
    Product Code
    LRP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT UNDERGOING ANGIOGRAM. THE PHYSICIAN HAND INJECTED THE CONTRAST FOR THE CATHETER PLACEMENT AND RECEIVED BLOOD RETURN. UPON RE-INJECTING THE CONTRAST AND BLOOD, THE SYRINGE RUPTURED. NO-ILL-EFFECTS TO THE PT. STAFF WAS SPRAYED WITH THE CONTENTS OF THE SYRINGE AND WAS TREATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SKLAR STERILE 20CC B & D SYRINGE - BIOPSY TRAY LRP SKLAR INSTRUMENTS NA 01003378

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other