BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING NITRILE POWDER FREE EXAM GLOVES

    MDR report key: 4905073 · Received July 2, 2015

    Report

    Report Number
    4905073
    Event Type
    Malfunction
    Date Received
    July 2, 2015
    Date of Event
    June 30, 2015
    Report Date
    July 2, 2015
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TWO BOXES OF HALYARD STERLING NITRILE POWDER FREE EXAM GLOVES WERE INVOLVED IN THIS EVENT. THE FIRST BOX IS SIZE SMALL. THE BOX WAS HALF EMPTY AND THE STAFF MEMBER PULLED OUT A GLOVE WHICH TORE.THE SECOND BOX IS SIZE MEDIUM. THE BOX IS BRAND NEW AND THE NURSE PULLED OUT THE FIRST FEW GLOVES AND THEY RIPPED WHEN SHE WENT TO PUT THEM ON. THE STAFF MEMBER WAS NOT WEARING ANY JEWELRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433363 STERLING NITRILE POWDER FREE EXAM GLOVES POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE LZA HALYARD HEALTH, INC. * SY5116ZZZ
    433364 STERLING NITRILE POWDER FREE EXAM GLOVES STERLING NITRILE POWDER FREE EXAM GLOVES LZA HALYARD HEALTH, INC. * SY5011ZZZ_03AX

    Patients

    Seq Age Sex Outcome Treatment
    1 *