BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2791822 · Received October 15, 2012

    Report

    Report Number
    1416980-2012-02466
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Report Date
    October 1, 2012
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: DURING THE VISUAL INSPECTION IT WAS OBSERVED THAT THE INLET OF THE Y-SITE WAS CHIPPED OFF FROM THE TOP. FUNCTIONAL TEST WAS NOT PERFORMED SINCE THE DEFECT WAS VISUALLY CONFIRMED. THIS ISSUE IS BEING INVESTIGATED THROUGH A CAPA. THE ROOT CAUSE OF THE DAMAGED Y-SITE HOUSING WAS DETERMINED TO BE THE AIR REGULATOR NOT BEING ACTIVATED.

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY IN THE PROCESS OF BEING EVALUATED. THE REPORTED MALFUNCTION, "Y SITE WAS DEFORMED" WAS CONFIRMED DURING SAMPLE EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TO REPORT AN INTERLINK Y-SITE THAT WAS DEFORMED. THERE WAS NO PATIENT INVOLVED, REPORTED 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 SR11J05030

    Patients

    Seq Age Sex Outcome Treatment
    1