BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 1 LITER

    MDR report key: 1354137 · Received February 19, 2009

    Report

    Report Number
    9613251-2009-00033
    Event Type
    Malfunction
    Date Received
    February 19, 2009
    Date of Event
    January 1, 2008
    Report Date
    December 15, 2008
    Manufacturer
    HOSPIRA, LTD.
    Product Code
    KDQ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE DISCARDED. THE CATALOG NUMBER PROVIDED IS THE INTERNATIONAL LIST NUMBER THAT WAS INVOLVED IN THE REPORTED EVENT WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME. THIS REPORT REPRESENTS ALL THE INFO KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL.

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF INADEQUATE SUCTION. AT UNSPECIFIED TIMES WHILE IN USE ON PATIENTS, IT WAS REPORTED THAT IT WAS NOT POSSIBLE TO BUILD UP HIGH PRESSURES ABOVE 120 TO 180 MMHG. 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 RECEPTAL 1 LITER UNK KDQ HOSPIRA, LTD. NA 67186KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK