BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PH/BLOOD GAS ANALYZER

    MDR report key: 4874 · Received July 21, 1992

    Report

    Report Number
    4874
    Event Type
    Injury
    Date Received
    July 21, 1992
    Date of Event
    March 6, 1991
    Report Date
    July 20, 1992
    Manufacturer
    INSTRUMENTATION LABORATORY
    Product Code
    CCC
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    EMPLOYEE ACCIDENTLY STUCK BY A CONTAMINATED NEEDLE WHICH IS PART OF THE MACHINE. THE TECHNICIAN WAS ACCIDENTLY CRUSHED AGAINST THE NEEDLE HOLDER, THAT DOES NOT SECURELY LOCK IN PLACE, WITH THE BACK OF HIS HAND. THE NEEDLE HOLDER FLIPPED AND THE TECHNICIAN WAS STUCK BY THE NEEDLE THAT COMES IN CONTACT WITH THE BLOOD SAMPLEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. INVALID DATA - REGARDING MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PH/BLOOD GAS ANALYZER CCC INSTRUMENTATION LABORATORY 1306

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention