BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNAPTIVE TRACKABLE SUCTION

    MDR report key: 11820012 · Received May 13, 2021

    Report

    Report Number
    3012075008-2021-00001
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 12, 2021
    Manufacturer
    SYNAPTIVE MEDICAL INC.
    Product Code
    GCX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN IN-HOUSE INSPECTION ON (B)(6) 2021 MULTIPLE SAMPLES WERE IDENTIFIED WITH VISIBLE BURRS/METAL FILINGS AFFIXED WITHIN THE SUCTION TUBE INTERIOR. TO DATE, THERE HAVE BEEN NO COMPLAINTS AND NO KNOWN PATIENT INJURIES RELATED TO THIS DEFECT. THIS RECALL AFFECTS ALL VERSIONS AND MODELS OF SYNAPTIVE¿ TRACKABLE SUCTION. NOTE: ALL AFFECTED SERIAL NUMBERS AND UDIS HAVE NOT BEEN INCLUDED IN THIS REPORT DUE TO SPACE CONSTRAINTS.

    Description of Event or Problem · 1

    ON (B)(6) 2021, DURING AN IN-HOUSE INSPECTION, AFFIXED BURRS/METAL FILINGS WERE OBSERVED ON THE SUCTION TUBE INNER PERIMETER. FURTHER INVESTIGATION REVEALED A PRODUCTION ISSUE, WHICH HAS RESULTED IN THE DECISION TO RECALL THE AFFECTED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    716322 SYNAPTIVE TRACKABLE SUCTION VACUUM-POWERED BODY FLUID SUCTION APPARATUS GCX SYNAPTIVE MEDICAL INC. N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1