BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUTION ADMINISTRATION SET

    MDR report key: 1913192 · Received December 2, 2010

    Report

    Report Number
    6000001-2010-05415
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PICTURES OF THE SAMPLE ARE REPORTED TO BE AVAILABLE BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTED INFORMATION: PICTURES OF THE SAMPLE ARE NOT AVAILABLE FOR EVALUATION AS PREVIOUSLY REPORTED. THE ACTUAL SAMPLE IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE REPORTED CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A SOLUTION ADMINISTRATION SET WHERE THE LOWER END OF THE Y CONNECTOR, THAT WAS ATTACHED TO THE PATIENT, CAME OUT OF THE PLASTIC CONTAINER AND THE PATIENT'S MEDICATION DID NOT INFUSE AND THE PATIENT LOST SOME BLOOD. NO PATIENT INJURY WAS REPORTED WITH THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLUTION ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10G31V244D

    Patients

    Seq Age Sex Outcome Treatment
    1