BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 1 LITER/CE

    MDR report key: 1359958 · Received March 6, 2009

    Report

    Report Number
    9613251-2009-00086
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    December 1, 2008
    Report Date
    January 7, 2009
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    KDQ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED DEVICE WAS EVALUATED. TESTING FOUND INADEQUATE SUCTION. THIS WAS DUE TO A CRACK IN THE LINER LID. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80GCX AND IS 510K EXEMPT. THE INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. THE EVENTS THAT ARE BEING REPORTED WERE NOTED DURING VERIFICATION TESTING. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE RPTR UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    DURING VERIFICATION TESTING AT THE MANUFACTURING FACILITY, INADEQUATE SUCTION WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL 1 LITER/CE UNK KDQ HOSPIRA, LTD. NA 67186KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA