BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECEPTAL 2L/CE W. NO

    MDR report key: 1461465 · Received May 15, 2009

    Report

    Report Number
    9613251-2009-00124
    Event Type
    Malfunction
    Date Received
    May 15, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 22, 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. (B) (4). THE INFO ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED LOSS OF SUCTION. IT WAS REPORTED THAT DURING TESTING OF THE DEVICE AFTER SUCTION HAD BEEN APPLIED FOR 24 HOURS, A CRACK WAS NOTED IN THE LINER LID; SUBSEQUENTLY, LOSS OF SUCTION WAS NOTED. THOUGH REQUESTED, NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECEPTAL 2L/CE W. NO NONE KDQ HOSPIRA, LTD NA 69146KZ

    Patients

    Seq Age Sex Outcome Treatment
    1 NA