BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 1 LITER/

    MDR report key: 1359994 · Received March 6, 2009

    Report

    Report Number
    9613251-2009-00062
    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 501K EXEMPT. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B) (4).

    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