BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHARPS CONTAINER

    MDR report key: 4156 · Received August 27, 1992

    Report

    Report Number
    4156
    Event Type
    Malfunction
    Date Received
    August 27, 1992
    Date of Event
    February 5, 1992
    Report Date
    February 10, 1992
    Manufacturer
    SAGE PRODUCTS INC.
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    R.N. WAS CHANGING LARGE SHARPS CONTAINER WHEN A NEEDLE PROTRUDING FROM THE SIDE OF THE CONTAINER PUNCTURED HIS LEFT FOURTH FINGER.DEVICE NOT LABELED FOR SINGLE USE. 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: UNKNOWN. SERVICE RECORDS NOT AVAILABLE.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHARPS CONTAINER SAGE PRODUCTS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other