BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERLING NITRILE POWDER FREE EXAM GLOVE

    MDR report key: 2455603 · Received February 14, 2012

    Report

    Report Number
    2455603
    Event Type
    Malfunction
    Date Received
    February 14, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 14, 2012
    Manufacturer
    KIMBERLY-CLARK
    Product Code
    LZA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VT, US

    Narratives

    Description of Event or Problem · 1

    AN ENVIRONMENTAL SERVICES (HOUSEKEEPING) WORKER REACHED FOR EXAM GLOVES TO USE DURING ROUTINE CLEANING DUTIES. THE WORKER OBSERVED THAT GLOVES WERE "CLUMPY". PULLING ONE GLOVE FROM THE BOX RESULTED IN ABOUT A DOZEN GLOVES COMING OUT IN A CLUMP. HOWEVER, CLOSER EXAMINATION REVEALED THAT WHERE GLOVES WERE STUCK TOGETHER, THE KNOT WAS QUITE HARD AND THAT GLOVES DID NOT SEPARATE EASILY.THIS RAISES CONCERNS ABOUT MIRCO-TEARS AND MICRO-PORES IN THE NITRILE MATERIAL, THEREBY NEGATING THE ABILITY OF THE GLOVE TO PROTECT THE WORKER.SINCE THIS MODEL OF NITRILE GLOVES ARE ALSO USED BY CARE GIVERS WHILE PROVIDING PATIENT CARE, THIS ALSO RAISES QUESTIONS ABOUT THE ABILITY OF THE GLOVE TO PROTECT PATIENTS RECEIVING CARE.THE MANUFACTURER WAS NOTIFIED AND THEY OPENED A COMPLAINT RECORD.======================MANUFACTURER RESPONSE FOR EXAM GLOVE, STERLING NITRILE POWDER FREE EXAM GLOVE (PER SITE REPORTER).======================THE MANUFACTURER REQUESTED THE RETURN OF THE DEFECTIVE PRODUCT. THE RETURN IS NOW PENDING THE RECEIPT OF RETURN GOODS AUTHORIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING NITRILE POWDER FREE EXAM GLOVE EXAM GLOVE LZA KIMBERLY-CLARK KC 300 SM129933BLXX

    Patients

    Seq Age Sex Outcome Treatment
    1 *