BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECONDARY IV SET-SL/

    MDR report key: 1511829 · Received October 6, 2009

    Report

    Report Number
    9615050-2009-00232
    Event Type
    Malfunction
    Date Received
    October 6, 2009
    Report Date
    September 8, 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
    UK
    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 11311. THE DOMESTIC LIST NUMBER HAS A COMMON DEVICE NAME OF 80FPK AND HAS A 510K OF K063239. THE REPORTER WAS CONTACTED AND INFORMATION ON REPROCESSING OF THE DEVICE WAS REQUESTED; HOWEVER, THE INFORMATION WAS NOT OBTAINED. 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 A LEAK OF A CHEMOTHERAPEUTIC AGENT. THE TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED CONCENTRATION OF VINCRISTINE. AFTER AN UNSPECIFIED LENGTH OF TIME IN USE, LEAKAGE OF SOLUTION WAS NOTED AT THE DRIP CHAMBER AND THE TUBING CONNECTION. THE VOLUME OF SOLUTION THAT LEAKED WAS UNSPECIFIED. THE TUBING SET WAS REPLACED AND THE THERAPY WAS RESUMED. THE SPILL WAS CLEANED UP ACCORDING TO THE HOSPITAL'S POLICY. THERE WERE NO REPORTED ADVERSE PATIENT 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 SECONDARY IV SET-SL/ UNK FPA HOSPIRA COSTA RICA LTD. NA 651075G

    Patients

    Seq Age Sex Outcome Treatment
    1