BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    560/570 SERIES BURETTE INFUSION SET

    MDR report key: 2853944 · Received October 24, 2012

    Report

    Report Number
    9616066-2012-00738
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 8, 2012
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K882302
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE INVOLVED IN THIS EVEN TWILL NOT BE RETURNED AS IT WAS NOT AVAILABLE. NO FAILURE INVESTIGATION COULD BE PERFORMED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING AN ETOPOSIDE CHEMOTHERAPY INFUSION, THE MOTHER OF THE PATIENT NOTICED THAT THE DRUG WAS LEAKING OUT OF THE TOP OF THE BURETTE. FROM THE REPORTED INFORMATION, THERE ARE NO INDICATIONS OF SERIOUS INJURY TO THE PATIENT OR USER AS A RESULT OF THIS INCIDENT. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 560/570 SERIES BURETTE INFUSION SET FPA CAREFUSION CORPORATION 5210FE 12055457

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN