BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25G POST VITRECTOMY PACK W WF

    MDR report key: 4102338 · Received August 27, 2014

    Report

    Report Number
    1920664-2014-00159
    Event Type
    Malfunction
    Date Received
    August 27, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION COMPLETED. (B)(4) 23GA VITRECTOMY CUTTER WAS RETURNED IN A SMALL PLASTIC ZIP LOCK BAG. THE ORIGINAL PACKAGING WAS NOT RETURNED. A PHOTO COPY OF THE PACK LABEL INDICATES IT WAS A (B)(4) PACK FROM LOT V2903. THE TIP PROTECTOR, BACK CAP, INNER NEEDLE AND THE TUBING WERE NOT RETURNED. THE CUTTER WAS IN PIECES. THE NEEDLE WAS NOT BENT. THERE WAS DRIED SOLUTION VISIBLE IN THE PORT OF THE NEEDLE. THE INTERNAL SPRING WAS LYING LOOSE IN THE BAG. MICROSCOPIC EXAMINATION OF THE CUTTER BODY RIM FOUND NO EVIDENCE OF ADHESIVE. IT CANNOT BE DETERMINED IF THE BACK CAP WAS CORRECTLY POSITIONED AND FULLY SEATED IN THE CUTTER BODY AT THE TIME OF CUSTOMER USE. THE CAUSE OF THE BACK CAP SEPARATING FROM THE CUTTER BODY CANNOT BE DETERMINED. FUNCTIONAL TESTING CANNOT BE PERFORMED DUE TO THE MISSING COMPONENTS. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 2 OF 2 SEE 1920664-2014-00158.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING. THERE WAS NO PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522779 STELLARIS 25G POST VITRECTOMY PACK W WF 25G POST VITRECTOMY PACK HQC BAUSCH & LOMB, INC. V2903

    Patients

    Seq Age Sex Outcome Treatment
    1