BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VACUTAINER

    MDR report key: 4315 · Received October 8, 1992

    Report

    Report Number
    4315
    Event Type
    Injury
    Date Received
    October 8, 1992
    Date of Event
    June 20, 1992
    Report Date
    August 7, 1992
    Manufacturer
    BECTON DICKINSON VACUTAINER SYSTEMS
    Product Code
    GIO
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    AN E.R. NURSE DREW TWO BLOOD CULTURES W/VACUTAINER IN TWO PLAIN RED TOP TUBES (10 ML). A 10CC SYRINGE (BECTON DICKINSON VACUTAINER SYSTEMS CATALOG #9604) WITH AN 18 GAUGE NEEDLE (BECTON DICKINSON VACUTAINER SYSTEMS CATALOG #5199) WAS USED TO WITHDRAW FIRST TRANSFER. DURING SECOND TRANSFER, THE GLASS TUBE SHATTERED SPRAYING BLOOD ON NURSE'S NOSE, MOUTH, EYES AND FACE. THE PATIENT'S BLOOD WAS HIV+. EYES WERE IMMEDIATELY WASHED WITH IL OF NSS. MOUTH RINSED AND NURSE GARGLED WITH ONE BOTTLE OF H202. NURSE TOOK COMPLETE SHOWER IMMEDIATELY AFTER EVENT.HIV AND HEPATITIS BASELINE TESTS WERE CONDUCTED ON THE NURSEINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT 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. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE NOT USED AS LABELED/INDENDED.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: DEVICE DISCARDED, OTHER. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VACUTAINER BLOOD TUBE GIO BECTON DICKINSON VACUTAINER SYSTEMS UNKNOWN 2C717

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention