BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2232271 · Received September 2, 2011

    Report

    Report Number
    6000001-2011-22303
    Event Type
    Malfunction
    Date Received
    September 2, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K003225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT 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.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER PRODUCT SURVEILLANCE OF A LUER ACTIVATED VALVE IN WHICH THERE ARE ISSUES DISCONNECTING A HOSPIRA PUMP SET FROM THIS LUER. THIS LUER IS CONNECTED TO AN EXTENSION SET. THE PROCESS STEP IN WHICH THIS CONDITION OCCURRED IS UNKNOWN. 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 SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1