BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 3L/CE P.E.

    MDR report key: 1421512 · Received March 23, 2009

    Report

    Report Number
    9613251-2009-00094
    Event Type
    Malfunction
    Date Received
    March 23, 2009
    Date of Event
    February 8, 2009
    Report Date
    February 24, 2009
    Manufacturer
    HOSPIRA LTD
    Product Code
    KDQ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICES WERE RECEIVED. INVESTIGATION IS NOT COMPLETED. (B) (4). (B) (4)

    Description of Event or Problem · 1

    GENERAL REPORT RECEIVED OF AN UNSPECIFIED NUMBER OF UNDOCUMENTED INCIDENTS OF LOSS OF SUCTION. AFTER UNSPECIFIED LENGTHS OF TIME IN USE, IT WAS REPORTED THAT "SUCTION CEASED BEFORE THE LINERS FILLED." THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL 3L/CE P.E. UNK KDQ HOSPIRA LTD NA 54190KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK