BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 1 LITER/CE

    MDR report key: 1359971 · Received March 6, 2009

    Report

    Report Number
    9613251-2009-00081
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    December 16, 2008
    Report Date
    December 16, 2008
    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. THE EVENT THAT IS BEING REPORTED WAS NOTED DURING VERIFICATION TESTING; THEREFORE, USER FACILITY EVENT CODES ARE NOT APPLICABLE IN THIS CASE. 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 65162KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA