BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEDIPLAST AUTOZERO WESTERGREN ESR SYSTEM

    MDR report key: 4308389 · Received October 14, 2014

    Report

    Report Number
    2435505-2014-00001
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 15, 2014
    Manufacturer
    LP ITALIANA SPA
    Product Code
    JPH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A (B)(4) SEDIPLAST PIPETTES WERE DISTRIBUTED IN THE US MARKET IN 2014 YTD AND THERE WERE NO OTHER INCIDENTS OF THIS NATURE. IN 2013, A SAFETY ALERT WENT OUT HIGHLIGHTING THE INSTRUCTIONS FOR USE. THE INSTRUCTIONS FOR USE STATE THAT IT IS IMPORTANT TO CAREFULLY AND GENTLY INSERT THE PIPETTE INTO THE BLOOD FILLED VIAL, WITHOUT HOLDING OR BLOCKING THE TOP OF THE PIPETTE. FROM 2013-2014 YTD, (B)(4) SEDIPLAST PIPETTES WERE DISTRIBUTED. AN INVESTIGATION IS CURRENTLY UNDERWAY TO DOCUMENT THE PROBABLE ROOT CAUSE OF THE INCIDENT AND ASSESS IF THERE IS ANY NECESSARY CORRECTIVE ACTION OR SAFETY ALERT REQUIRED.

    Description of Event or Problem · 1

    POLYMEDCO RECEIVED A CUSTOMER CALL STATING THAT WHILE ONE OF THEIR LAB TECHS WAS INSERTING A SEDIPLAST PIPETTE INTO THE BLOOD FILLED VIAL, THE TOP OF THE PIPETTE POPPED OFF AND BLOOD SPRAYED OUT. THE LAB TECH WAS NOT WEARING ANY FACIAL PERSONAL PROTECTIVE EQUIPMENT OR USING A LAB SHIELD. THE LAB TECH WAS SPRAYED IN THE FACE WITH BLOOD, SENT TO THE EMERGENCY ROOM FOR A BODILY FLUID EXPOSURE WORKUP AND RELEASED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652113 SEDIPLAST AUTOZERO WESTERGREN ESR SYSTEM SEDIPLAST JPH LP ITALIANA SPA NP T0310A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other