BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SG3

    MDR report key: 7270334 · Received February 14, 2018

    Report

    Report Number
    3003902955-2018-00004
    Event Type
    Malfunction
    Date Received
    February 14, 2018
    Date of Event
    November 13, 2017
    Report Date
    February 14, 2018
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO EVALUATION COULD BE CONDUCTED DUE TO THE DEVICE NOT BEING RETURNED. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. WITH NO DEVICE RETURN THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DEFINITIVELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT FILES. PRIOR TO SHIPMENT, QC CONDUCTS OUTGOING VISUAL INSPECTION TO ASSURE LOTS BEING SHIPPED ARE IN GOOD QUALITY. TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF TERUMO (PHILIPPINES) CORPORATION (MANUFACTURER) REGISTRATION NO. 3003902955. EXEMPTION NUMBER E2015017.

    Additional Manufacturer Narrative · 0

    PATIENT THAT WAS BEING TREATED INFORMATION: (B)(6). SEX - FEMALE. (B)(6).

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED A DEVICE FAILURE, WHICH OCCURRED AT THE (B)(6) ON (B)(6) 2017. THE USER FACILITY REPORTED THAT A VACCINE WAS GIVEN TO A PATIENT AND AFTERWARD'S TAPPED THE SURGUARD3 SAFETY HYPODERMIC NEEDLE AGAINST THE ARM OF THE EXAM CHAIR TO ENGAGE THE SAFETY MECHANISM. THE PATIENT REPORTED THAT BEFORE THE NURSE TURNED TO PLACE THE DEVICE IN THE SHARPS CONTAINER, MOVEMENT OF MY HANDS CAUSED THE DEVICE IN MY RIGHT HAND TO COME IN CONTACT WITH MY LEFT MIDDLE FINGER, PIERCING THE SKIN AND DRAWING BLOOD. IT WAS THEN THAT I NOTICED THAT, ALTHOUGH THE SAFETY MECHANISM WAS LOCKED, IT APPEARED TO HAVE TWISTED AND THE TIP OF THE NEEDLE WAS NOT COVERED BY THE SAFETY MECHANISM. IT WAS REPORTED THAT THE PATIENT IS DOING WELL. ALL EMPLOYEES WERE TESTED AND ALL THEIR BLOOD WORK CAME BACK NEGATIVE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 1/30/2018: THE PATIENT THAT WAS BEING TREATED AND THE NURSE WHO WAS STUCK WITH THE NEEDLE WERE BOTH TESTED. THERE WAS NO IMPACT TO THE PATIENT THAT WAS BEING TREATED. ALL THE BLOOD WORK CAME BACK NEGATIVE FOR BOTH THE NURSE AND THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115644 UNK SG3 SYRINGE, ANTISTICK MEG TERUMO PHILIPPINES CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR