BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    250123/MONOJECT

    MDR report key: 5808 · Received July 1, 1993

    Report

    Report Number
    5808
    Event Type
    Malfunction
    Date Received
    July 1, 1993
    Date of Event
    May 23, 1993
    Report Date
    June 7, 1993
    Manufacturer
    SHERWOOD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    NURSE WAS PUTTING A CLEAN NEEDLE (MONOJECT 20 GA) IN IV TUBING. NEEDLE WAS BENT AND AS NURSE PUSHED IT (IN THE CASE) INTO THE TUBING, THE BENT POINT CAME THROUGH THE CASE INTO THE NURSE'S THUMB. HARM CAN BE CAUSED TO THE NURSE BY HANDS OR GLOVES BEING CONTAMINATED, ORGANISMS CAN BE INTRODUCED INTO THE BLOOD STREAM. THE NURSE WAS SEEN IN THE EMERGENCY DEPARTMENT WHERE SHE WAS TREATED AND RELEASEDDEVICE 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: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. 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: MANUFACTURING. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 250123/MONOJECT HYPODERMIC NEEDLE 20GA. FMI SHERWOOD N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other