BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUSET 100 BURETTE

    MDR report key: 1457255 · Received May 1, 2009

    Report

    Report Number
    9615050-2009-00085
    Event Type
    Malfunction
    Date Received
    May 1, 2009
    Date of Event
    April 1, 2009
    Report Date
    April 10, 2009
    Manufacturer
    HOSPIRA COSTA RICA LTD.
    Product Code
    FPA
    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 WAS INVOLVED IN THE REPORTED EVENT WHICH IS COMPARABLE TO THE DOMESTIC LIST NUMBER 12722. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPK AND A 501K OF K063239. (B) (4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THE FLOAT VALVE IN THE SOLUSET DID NOT CLOSE WHEN THE SOLUSET EMPTIED. THE SOLUSET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, THE FLOAT VALVE IN THE SOLUSET DID NOT CLOSE WHEN THE SOLUSET EMPTIED. THERE WERE NO REPORTED ADVERSE PT EFFECTS. NO MEDICAL INTERVENTIONS WERE REPORTED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUSET 100 BURETTE UNK FPA HOSPIRA COSTA RICA LTD. NA 380405G

    Patients

    Seq Age Sex Outcome Treatment
    1