BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTELLIFILL I.V.

    MDR report key: 2222358 · Received August 18, 2011

    Report

    Report Number
    3004771245-2011-00002
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    January 5, 2011
    Report Date
    August 18, 2011
    Manufacturer
    BAZA SYSTEMS DEVELOPMENT CENTER
    Product Code
    NEP
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED RETROSPECTIVELY DUE TO A ROUTINE MONITORING OF THE MAUDE DATABASE ON (B)(4) 2011. (PAGE 3 OF 4 AND PAGE 4 OF 4) WITH NARRATIVE. IN CONCLUSION, THE POSITIVE GROWTH SYRINGES REPORTED BY OUR CUSTOMER, (B)(6), WAS LIKELY CAUSED BY A NUMBER OF FACTORS. THE MONITORING PROGRAM AND THE INTELLIFILL I.V. DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    A ROUTINE MONITORING OF THE MAUDE DATABASE ON (B)(6) 2011 BAXA LEARNED THAT A MEDWATCH THAT WAS REPORTED ON (B)(6) 2011. AS A RESULT BAXA SYSTEMS DEVELOPMENT CENTER IS FILING THIS MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELLIFILL I.V. PHARMACY COMPOUND DEVICE NEP BAZA SYSTEMS DEVELOPMENT CENTER INTELLIFILL I.V. NA

    Patients

    Seq Age Sex Outcome Treatment
    1