BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 1 LITER/

    MDR report key: 1360003 · Received March 6, 2009

    Report

    Report Number
    9613251-2009-00058
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    January 1, 2009
    Report Date
    February 6, 2009
    Manufacturer
    HOSPIRA LTD.
    Product Code
    KDQ
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED THAT THE DEVICE WAS DISCARDED. 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 EXEMPT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. IT WAS REPORTED THAT DURING TESTING OF THE DEVICE WHEN SUCTION WAS APPLIED, CRACKS WERE NOTED ON THE LID OF THE LINER; SUBSEQUENTLY, LOSS OF SUCTION WAS NOTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL 1 LITER/ UNK KDQ HOSPIRA LTD. NA 68013KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA