BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2881797 · Received December 20, 2012

    Report

    Report Number
    1416980-2012-07786
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FURTHER INVESTIGATION IT HAS BEEN IDENTIFIED THAT THIS MALFUNCTION WOULD NOT REASONABLY CAUSE DEATH OR SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TO REPORT AN INTERLINK SYSTEM SECONDARY MEDICATION SET THAT "TEARS EASILY". THE CUSTOMER STATED THAT THE PLASTIC TEARS EASILY AND THAT THE OPERATOR'S FINGER WENT THROUGH THE PLASTIC. IT IS UNKNOWN IN WHAT PROCESS STEP THAT THIS MALFUNCTION OCCURRED. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT, PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE ST1011122

    Patients

    Seq Age Sex Outcome Treatment
    1