BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2193940 · Received August 5, 2011

    Report

    Report Number
    6000001-2011-16850
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    KPE
    PMA / PMN Number
    K964853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED NOR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS PERFORMED ON THE REPORTED LOT AND NO DEVIATIONS WERE NOTED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. ADDITIONAL INVESTIGATION IS BEING CONDUCTED THRU (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4) - THE SAMPLE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE OR THE SAMPLE IS RECEIVED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BAXTER SALES REPRESENTATIVE (BSR) CALLED CORPORATE PRODUCT SURVEILLANCE (CPS) (B)(4) TO RELAY CUSTOMER REPORT RECEIVED (B)(6) 2011 FOR UNKNOWN QUANTITY OF INTRAVIA EMPTY CONTAINER (150ML) GAMMA STERILIZED, PRODUCT CODE 2B8011, LOT NUMBER(S) UNKNOWN, IN WHICH UNSPECIFIED IV SET SPIKE "IS IMPOSSIBLE TO REMOVE" FROM THE EMPTY CONTAINER PORT AFTER USE. BSR ADVISED THAT SHE ASKED THE CUSTOMER IF THERE WAS ANY DIFFERENCE IF THE BAG WAS EMPTY OR FULL AND THAT THE CUSTOMER SAID THE PROBLEM OCCURS REGARDLESS OF THE FILL VOLUME. BSR RELAYED THAT THE CUSTOMER DOES NOT THINK THAT THE IV SETS ARE THE SOURCE OF THE PROBLEM; THAT IT DOES NOT MATTER WHICH SET IS USED. BSR RELAYED THAT THE CUSTOMER STATED THE PROBLEM HAS BEEN RECURRING SINCE (B)(6) 2011. BSR RELAYED THAT THE CUSTOMER HAS ONE AVAILABLE SAMPLE HAVING LOT NUMBER UR10A25177. BSR STATED THAT NO PATIENT INVOLVEMENT, INJURY OR ADVERSE EVENT IS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE CONTAINER, I.V. KPE BAXTER HEALTHCARE - AIBONITO UR10A25177

    Patients

    Seq Age Sex Outcome Treatment
    1