BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAMILTON CORE TIPS 50UL

    MDR report key: 2568639 · Received May 6, 2012

    Report

    Report Number
    MW5025324
    Event Type
    Injury
    Date Received
    May 6, 2012
    Report Date
    May 6, 2012
    Manufacturer
    HAMILTON COMPANY
    Product Code
    JTC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PRODUCT CONTAMINATION POSSIBILITY: FAILURE OF CLEANROOM HEPA AIR FILTRATION SYSTEM WHERE VARIOUS DISPOSABLE STERILE IVD PRODUCTS ARE MANUFACTURED (CLEAR AND CONDUCTIVE PIPETTE TIPS IN SEVERAL SIZES, REAGENT TUBS AND LIDS). THE HEPA SYSTEM MAINTAINS CLEAN POSITIVE AIR PRESSURE IN THE CLEANROOM. IT WAS SUSPECTED OF FAILURE (30%) IN (B)(6) 2010. THE PROBLEM WAS CONFIRMED IN (B)(6) 2011 AT LESS THAN 50% FUNCTIONAL. REPAIRS WERE COMPLETE DIN (B)(6) 2012 TO BRING THE SYSTEM TO 100% FUNCTIONALITY. ALL PRODUCTS MANUFACTURED BETWEEN (B)(6) 2010 AND (B)(6) 2012 SHOULD BE CONSIDERED SUSPECT UNLESS EVIDENCE OF AN ACCEPTABLE PARTICULATE COUNT THROUGHOUT THIS PERIOD CAN BE PROVIDED. CLEAN ROOM IS OWNED AND OPERATED BY: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAMILTON CORE TIPS 50UL DISPOSABLE PIPETTE TIPS JTC HAMILTON COMPANY NUMEROUS LOTS BY DAT
    2 HAMILTON CORE TIPE 300UL DISPOSABLE PIPETTE TIPS JTC HAMILTON COMPANY NUMEROUS LOTS BY DAT
    3 HEMILTON CORE TIPS 1000UL DISPOSABLE PIPETTE TIPS JTC HAMILTON COMPANY NUMEROUS LOTS BY DAT
    4 REAGENT CONTAINERS DISPOSABLE PIPETTE TIPS JTC HAMILTON COMPANY NUMEROUS LOTS BY DAT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S