BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SAF-T HOLDER BLOOD CULTURE DEVICE WITH MALE LUER

    MDR report key: 759672 · Received September 12, 2006

    Report

    Report Number
    1217052-2006-00074
    Event Type
    Injury
    Date Received
    September 12, 2006
    Date of Event
    August 1, 2006
    Report Date
    September 1, 2006
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    GJE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS EVALUATION: SMITHS MEDICAL ASD, INC. IS UNABLE TO FULLY EVALUATE THIS REPORT. THERE HAS BEEN NO LOT NUMBER OR SAMPLE GIVEN FOR EVALUATION. A REVIEW OF MANUFACTURING RECORDS CANNOT BE PERFORMED DUE TO THE INSUFFICIENT INFORMATION. A REVIEW OF DEVICE LABELING STATES: 6.3 AFTER USE, PLACE SHARPS IN A SUITABLE SHARPS CONTAINER. DISPOSE OF CONTAMINATED PRODUCT IN A SAFE MANNER ACCORDING TO CENTERS FOR DISEASE CONTROL AND PREVENTION, USA AND FEDERAL/STATE/LOCAL REGULATIONS (EPA, OSHA) AND HEALTH CARE FACILITY GUIDELINES OR LOCAL EQUIVALENT.

    Description of Event or Problem · 1

    USER ALLEGES CLINICIAN RECEIVED A NEEDLE STICK WHEN TRYING TO PUSH A SAF-T HOLDER INTO A FULL SHARP CONTAINER. THE FLAP OF THE SHARPS CONTAINER WOULD NOT SWING. THE CLINICIAN WAS TRYING TO PUSH THE UNIT THROUGH AND WHEN TRYING TO PUSH THE UNIT IN WAS STUCK ON THE FINGER WITH THE BACK-END NEEDLE. TREATMENT WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAF-T HOLDER BLOOD CULTURE DEVICE WITH MALE LUER TRAY, BLOOD COLLECTION GJE SMITHS MEDICAL ASD, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention SHARPS CONTAINER