BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM ASPIRATION PUMP CANISTER

    MDR report key: 1930320 · Received November 18, 2010

    Report

    Report Number
    3005168196-2010-00683
    Event Type
    Malfunction
    Date Received
    November 18, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    PENUMBRA INC.
    Product Code
    BTA
    PMA / PMN Number
    K051758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION: THE CENTRAL PORTION OF THE LID IS BROKEN AND THE BODY OF THE CANISTER IS BROKEN AND MISSING PIECES. THE CANISTER IS NON FUNCTIONAL. CONCLUSION: THE DAMAGE OBSERVED DURING EVAL IS CONSISTENT WITH THE COMPLAINT DESCRIPTION. THE PLASTIC OF THE CANISTER LID IS COMPARATIVELY MORE BRITTLE THAN CURRENT STOCKED PARTS.

    Description of Event or Problem · 1

    THE PUMP CANISTER LID "EXPLODED" WHEN THE ASPIRATION PUMP WAS TURNED ON DURING A DEMONSTRATION AT THE HOSP BY A PENUMBRA SALES REP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM ASPIRATION PUMP CANISTER POWERED SUCTION PUMP BTA PENUMBRA INC.

    Patients

    Seq Age Sex Outcome Treatment
    1