BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W AFI AND FF 6/BX

    MDR report key: 4219268 · Received October 28, 2014

    Report

    Report Number
    1920664-2014-00219
    Event Type
    Malfunction
    Date Received
    October 28, 2014
    Date of Event
    September 30, 2014
    Report Date
    September 30, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED RECEIVED ONE BL5425W PACK FROM LOT V2979. THE PACK WAS RETURNED IN A BIOHAZARD BAG. THIS PACK CONTAINS A 25A VITRECTOMY CUTTER WHICH WAS LOOSE IN THE PACK TRAY. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS NOT BENT. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE TUBING. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. THE CONNECTORS WERE INSPECTED AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE CUTTER HAD GOOD CLEAN CUTS THROUGHOUT THE VARIOUS CUT RATES. THE CUTTER ASPIRATED AND PERFORMED AS INTENDED. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 1 OF 3. SEE 1920644-2014-00224 AND 00225.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THE VITRECTOMY CUTTER WAS NOT CUTTING AT 4000 CPM, AND WOULD NOT ASPIRATE. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690362 STELLARIS 25GA POSTERIOR PACK W AFI AND FF 6/BX 25GA POSTERIOR PACK HQC BAUSCH & LOMB, INC. V2979

    Patients

    Seq Age Sex Outcome Treatment
    1