BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RECONSTITUTION DEVICE

    MDR report key: 1850504 · Received October 1, 2010

    Report

    Report Number
    6000001-2010-03702
    Event Type
    Malfunction
    Date Received
    October 1, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 6, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US. THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ROOT CAUSE COULD NOT BE DETERMINED. BATCH REVIEW WAS CONDUCTED AND NO DEVIATIONS WHERE OBSERVED. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE TRANSFERRING ANTIBIOTICS INTO A VIAFLO BAG, THE TRANSFER NEEDLE BROKE AND WAS STUCK INTO EITHER THE VIAL CAP OR THE VIAFLO INJECTION PORT. THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION OCCURRED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 3 OF 3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RECONSTITUTION DEVICE UNKNOWN, DISPOSABLE FPA BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1