BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS 25GA POSTERIOR PACK W WF

    MDR report key: 3126341 · Received May 14, 2013

    Report

    Report Number
    1920664-2013-00103
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    March 4, 2013
    Report Date
    April 16, 2013
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K101325
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED. THE 25GA CUTTER WAS RETURNED IN PLASTIC BIOHAZARD ZIP LOCK BAG ALONG WITH THE BL5225 PACK LABELS FROM LOT U9701. THE TIP PROTECTOR WAS NOT RETURNED. THE NEEDLE WAS BENT APPROX 90 DEGREES. THE PORT WINDOW WAS IN THE OPENED POSITION. THERE WAS DRIED SOLUTION VISIBLE IN THE ASPIRATION LINE. THE BACK CAP WAS ALIGNED CORRECTLY WITH THE VENT HOLE IN THE SIDE OF THE CUTTER BODY. FUNCTIONAL TESTING FOUND THE CUTTER WILL NOT CUT AS THE INNER NEEDLE CANNOT MOVE DUE TO THE SEVERE BENT CONDITION. THE STERILIZATION AND LOT HISTORY RECORDS HAVE BEEN REVIEWED AND FOUND TO BE ACCEPTABLE. REPORT 3 OF 5. SEE 1920664-2013-00101, 1920664-2013-00102, 1920664-2013-00104, AND 1920664-2013-00105.

    Description of Event or Problem · 1

    THE USER FACILITY INITIALLY REPORTED DURING SURGERY THE CUTTER STOPPED WORKING AND ASPIRATION WAS LOST. NO PATIENT INJURY WAS REPORTED. ADD'L INFO RECEIVED WITH THE RETURNED PRODUCT: THE CUTTER DID NOT WORK; HOWEVER THE ASPIRATION CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213753 STELLARIS 25GA POSTERIOR PACK W WF HQC BAUSCH & LOMB, INC. BL5225 U9701

    Patients

    Seq Age Sex Outcome Treatment
    1