BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WHEATON UD VIALS

    MDR report key: 516687 · Received March 11, 2004

    Report

    Report Number
    MW1031493
    Event Type
    Injury
    Date Received
    March 11, 2004
    Manufacturer
    WHEATON MEDIA SYSTEMS
    Product Code
    KPE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRAGMENTS OF BROKEN GLASS DISCOVERED IN AS-PACKAGED; AS-RECEIVED BOXES OF AMBER GLASS VIALS. ONE BROKEN VIAL WITHIN EACH OF TWO PACKAGES.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 7/21/2004: MFR IS IN RECEIPT OF MOST RECENT NOTICE INVOLVING MW #1031493 AS WELL AS THE ORIGINAL NOTICE THAT WAS DATED MARCH 29, 2004. UPON REVIEW OF THIS COMPLAINT MFR HAS CONCLUDED THAT THIS PRODUCT IS NOT COVERED UNDER THE REQUIREMENTS FOR MEDICAL DEVICE REPORTING. THE REASON IS THAT THE ITEM INVOLVED IS NOT A MEDICAL DEVICE BUT IS CLASSIFIED AND SOLD AS A GENERAL LABORATORY PRODUCT. HOWEVER, IN AN EFFORT TO TRY AND ADDRESS THIS ALLEGED COMPLAINT, MFR HAS MADE ATTEMPTS TO CONTACT THE INDIVIDUAL WHO SUBMITTED THE REPORT THROUGH THE FDA MEDWATCH PRODUCTS REPORTING PROGRAM. THE PURPOSE OF REQUEST WAS TO TRY AND OBTAIN ADDITIONAL INFO THAT WOULD IDENTIFY MFR AS THE MANUFACTURER AND IN TURN ASSIST IN INVESTIGATION. LETTERS WERE SENT TO THE PARTY INVOLVED ON APRIL 20, 2004 AND JUNE 16, 2004. TO DATE THERE HAS BEEN NO CONTACT WITH THE INDIVIDUAL INVOLVED. THEREFORE, IN LIGHT OF FAILED ATTEMPTS TO REACH THE RESPONSIBLE PERSON AND THE FACT THAT THIS PRODUCT IS NOT COVERED UNDER THE MEDICAL DEVICE REPORTING ACT, MFR IS CLOSING THE FILE ON THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WHEATON UD VIALS UNIT DOSE GLASS VIALS - 15 ML SIZE KPE WHEATON MEDIA SYSTEMS 2738169 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention