BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2242121 · Received September 9, 2011

    Report

    Report Number
    6000001-2011-23779
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 19, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) ADDITIONAL INFORMATION: A 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.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNKNOWN IF THE SAMPLE IS AVAILABLE FOR EVALUATION. HOWEVER, IF THE CUSTOMER DECIDES TO SEND IN THE SAMPLE, A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION HAS BEEN PERFORMED. THE PRODUCT CODE OF THIS DEVICE USED IN THIS SITUATION IS UNKNOWN; THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF AN UNKNOWN SET IN WHICH THE DISTAL END CAP WAS DIFFICULT TO TAKE OFF AND REQUIRED SOME NURSES TO USE A HEMOSTAT IN ORDER TO TAKE IT OFF ONCE IT GOT WET. THIS CONDITION OCCURRED AT AN UNKNOWN PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1