BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2162754 · Received July 14, 2011

    Report

    Report Number
    6000001-2011-11960
    Event Type
    Malfunction
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    LHI
    PMA / PMN Number
    K973654
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR 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 COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO CORPORATE PRODUCT SURVEILLANCE REGARDING AN UNKNOWN QUANTITY OF VIAL-MATE ADAPTORS IN WHICH A NO-FLOW WAS DETECTED AFTER ACTIVATING UNSPECIFIED SOLUTION BAGS ON UNKNOWN DATE(S). THE CONDITION OCCURRED DURING RECONSTITUTION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, IV FLUID TRANSFER LHI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SOLUTION