BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLARIS MICRO INCISION VACUUM PK 6/BX

    MDR report key: 3897190 · Received May 21, 2014

    Report

    Report Number
    1920664-2014-00073
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    April 22, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BAUSCH & LOMB, INC.
    Product Code
    HQC
    PMA / PMN Number
    K063331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL COMPLETED. ONE COLLECTION CASSETTE ASSEMBLY WITH TUBING WAS RETURNED IN A PLASTIC BAG ALONG WITH A (B)(4) PACK LABEL FROM LOT V2304. THERE WAS FLUID ALL OVER INSIDE THE BAG. VISUAL INSPECTION FOUND THE ASSEMBLY HAS FLUID IN THE LINES. A FUNCTIONAL TEST WAS PERFORMED USING A STELLARIS PC SYSTEM. THE COLLECTION CASSETTE WAS CAPTURED, RECOGNIZED AND PASSED THE SELF VACUUM TEST. THE ASSEMBLY PRIMED, IRRIGATED AND ASPIRATED AS INTENDED. THE ASSEMBLY WAS NOT BLOCKED OR CLOGGED. THE STERILIZATION AND LOT HISTORY RECORDS WERE REVIEWED AND FOUND TO BE ACCEPTABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED DURING THE SURGICAL PROCEDURE THE STABLE CHAMBER TUBING BECAME CLOGGED. THEY DISCONNECTED THE TUBING AND USED A SYRINGE TO CLEAR THE DEBRIS. THEY COMPLETED THE SURGERY WITH NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303360 STELLARIS MICRO INCISION VACUUM PK 6/BX HQC BAUSCH & LOMB, INC. V2304

    Patients

    Seq Age Sex Outcome Treatment
    1