BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK SG3

    MDR report key: 7033277 · Received November 15, 2017

    Report

    Report Number
    3003902955-2017-00034
    Event Type
    Malfunction
    Date Received
    November 15, 2017
    Report Date
    November 15, 2017
    Manufacturer
    TERUMO PHILIPPINES CORPORATION
    Product Code
    MEG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXPIRATION DATE - UNKNOWN DUE TO THE LOT NUMBER BEING UNKNOWN. THE 510K - UNKNOWN DUE TO THE PRODUCT CODE BEING UNKNOWN. THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION AND THE PRODUCT CODE AND LOT ARE UNKNOWN. 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 AND ALL SAMPLES FOR THE COMPLAINT LOT PASSED. THE SAME USER FACILITY REPORTED SIMILAR EVENTS FOR OTHER DEVICES. SEE MDR 3003902955-2017-00033, 3003902955-2017-00037, AND 3003902955-2017-00038. 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.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED A NEEDLE STICK INCIDENT BY A NEWLY CONVERTED CUSTOMER. IT WAS REPORTED DIFFICULTY WITH ACTIVATING THE SAFETY NEEDLE COVER OF THE TERUMO SURGUARD 3 SAFETY NEEDLE. IT WAS REPORTED THAT IT IS DIFFICULT TO GET THE COVER TO CLOSE OVER THE NEEDLE AND ONE COMPLAINT SPECIFICALLY CITED DIFFICULTY WITH THUMB ACTIVATION OF THE NEEDLE COVER. NO KNOWN IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814148 UNK SG3 SYRINGE, ANTISTICK MEG TERUMO PHILIPPINES CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1