BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2232011 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22238
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    July 28, 2011
    Report Date
    August 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TWO ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE RETURNED SAMPLES REVEALED THAT THE CYTOLUERS WERE ATTACHED TO A VIAFLO BAG WITHOUT DIFFICULTY AND RECONSTITUTION COULD BE PERFORMED. THEREFORE, THE REPORTED CONDITION WAS NOT CONFIRMED AND NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. TWO OF THE TEN ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION.

    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. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A CYTO LUER SET IN WHICH COULD NOT BE CONNECTED TO VIAFLO BAGS. THE CONDITION WAS IDENTIFIED BEFORE PATIENT USE; THEREFORE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 10 OF 10 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS ADMINISTRATION, SET, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 11B28V491M

    Patients

    Seq Age Sex Outcome Treatment
    1