BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2100 ML LINER W/EXTERNAL VALVE

    MDR report key: 1002616 · Received February 8, 2008

    Report

    Report Number
    9613251-2008-00030
    Event Type
    Malfunction
    Date Received
    February 8, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 15, 2008
    Manufacturer
    HOSPIRA LTD.
    Product Code
    GCX
    PMA / PMN Number
    K893741
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IN UNK. A REP DEVICE FROM THE LOT NUMBERS 53001KZ AND 54105KZ WAS RECEIVED. INVESTIGATION IS NOT COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. TWO SUCTION LINERS WERE BEING USED IN A TANDEM SET UP DURING A LAPAROSCOPIC PROCEDURE IN THE OR. IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, THE SECOND LINER IN THE TANDEM SET UP "IMPLODED". LOSS OF SUCTION WAS REPORTED. THE CUSTOMER CONTACT COULD NOT SPECIFY THE VACUUM PRESSURE AT THE TIME OF THE EVENT. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2100 ML LINER W/EXTERNAL VALVE 79-GCX GCX HOSPIRA LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR