BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NON-PVC RECEPT. LINER 2000ML/CE(50/CS)

    MDR report key: 2151457 · Received June 21, 2011

    Report

    Report Number
    9613251-2011-00126
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    April 8, 2011
    Report Date
    April 8, 2011
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    GCX
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT COMPLETE. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT, WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER LISTED IN THE "OTHER" FIELD. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80GCX AND HAS A 510K OF K831939. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. THE DEVICE WAS BEING USED TO SUCTION FLUID DURING AN UNSPECIFIED LAPAROSCOPIC HERNIA SURGICAL PROCEDURE AND LAPAROSCOPIC CHOLECYSTECTOMY. IT WAS REPORTED THAT BETWEEN 45 MINUTES TO ONE HOUR IN USE, THE DEVICE REPORTEDLY BURST FROM THE SUCTION CONTAINER. A LOSS OF SUCTION WAS NOTED. MULTIPLE UNSUCCESSFUL ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION INCLUDING THE SPECIFIC EVENT DETAILS AND THE PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NON-PVC RECEPT. LINER 2000ML/CE(50/CS) UNK GCX HOSPIRA, LTD. NA 85007KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK