BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCA HBA1C CONTROL

    MDR report key: 542468 · Received September 3, 2004

    Report

    Report Number
    1217157-2004-00008
    Event Type
    Injury
    Date Received
    September 3, 2004
    Date of Event
    August 10, 2004
    Report Date
    September 3, 2004
    Manufacturer
    BAYER CORP.
    Product Code
    LDC
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    TECHNICIAN WAS WEARING GLOVES WHILE RECONSTITUTING VIAL OF HBA1C NORMAL CONTROL. WHEN OPENING THE GLASS VIAL, IT "CRUMBLED IN TECHNICIAN'S FINGERS." THE GLASS SHARDS CUT THROUGH TECHNICIAN'S GLOVES AND CUT THE TECHNICIAN. CUT OCCURRED TO TECHNICIAN'S LEFT THUMB AND RIGHT INDEX FINGER. PER CUSTOMER, "IT WAS NOT A DEEP CUT." TECHNICIAN IMMEDIATELY CLEANED THE AREA WITH ANTISEPTIC. NO STITCHES WERE REQUIRED. ALL THE CONTROL CONTAINER AND MATERIAL WAS DISCARDED. OCCUPATIONAL HEALTH NURSE RN, WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DCA HBA1C CONTROL QC CONTROL (NORMAL) LDC BAYER CORP. NA 0018

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other