BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1ML SAF. SYR ETB 28X1/2

    MDR report key: 8531363 · Received April 19, 2019

    Report

    Report Number
    1915484-2019-01044
    Event Type
    Malfunction
    Date Received
    April 19, 2019
    Date of Event
    March 20, 2019
    Report Date
    April 19, 2019
    Manufacturer
    COVIDIEN
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE LPN ADMINISTERED PPD USING COVIDIEN MONOJECT 1ML TUBERCULIN SAFETY SYRINGE. THE NEEDLE SAFETY SHIELD DID NOT ENGAGE AFTER USE. THE NURSE WAS ABLE TO SLIDE SAFETY SHIELD BACK AND FORTH OVER THE NEEDLE SEVERAL TIMES WITHOUT FORCE. THE LOCK DID NOT ENGAGE. THE NEEDLE WAS DISPOSED OF IN A SHARPS CONTAINER TO PREVENT ACCIDENTAL NEEDLESTICK. NO INJURY OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323705 1ML SAF. SYR ETB 28X1/2 SYRINGE, PISTON FMF COVIDIEN 8881511201 631950X

    Patients

    Seq Age Sex Outcome Treatment
    1