BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCHNEIDER/NAMIC SYRINGE

    MDR report key: 95359 · Received May 30, 1997

    Report

    Report Number
    1317056-1997-00020
    Event Type
    Malfunction
    Date Received
    May 30, 1997
    Date of Event
    May 5, 1997
    Report Date
    May 30, 1997
    Manufacturer
    SCHNEIDER/NAMIC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE END USER HOSPITAL REPORTED RECEIVING A SYRINGE WITH A "PIECE OF PLASTIC" FLOATING IN IT WITHIN THEIR CUSTOM KIT. NO PT INJURY WAS INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHNEIDER/NAMIC SYRINGE 10CC ANGIOGRAPHIC SYRINGE DXT SCHNEIDER/NAMIC NA 368496

    Patients

    Seq Age Sex Outcome Treatment
    1 NA