BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONVERTBL I.V..DUAL C

    MDR report key: 1485747 · Received August 13, 2009

    Report

    Report Number
    9613251-2009-00189
    Event Type
    Malfunction
    Date Received
    August 13, 2009
    Date of Event
    July 1, 2009
    Report Date
    July 15, 2009
    Manufacturer
    HOSPIRA LTD.
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER INDICATED 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 11879. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPA AND HAS A 510K OF K933326. DOCUMENTATION RECEIVED FROM THE REPORTER INDICATE THAT INFO ON REPROCESSING OF THE DEVICE WAS UNK. (B) (4). (B) (4)

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF TAXOL. IT WAS REPORTED THAT PRIOR TO PT USE, THE PHARMACY ASSISTANT NOTED SOLUTION LEAKED FROM THE TUBING. THE TUBING SET WAS REPLACED. THERE WERE NO REPORTED ADVERSE EFFECT TO THE HEALTHCARE PROFESSIONAL. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONVERTBL I.V..DUAL C UNK FPA HOSPIRA LTD. NA UNKKZ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK