BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2173493 · Received July 23, 2011

    Report

    Report Number
    6000001-2011-13556
    Event Type
    Malfunction
    Date Received
    July 23, 2011
    Date of Event
    March 15, 2011
    Report Date
    March 18, 2011
    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). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. A VISUAL INSPECTION WAS PERFORMED AND THE INJECTION SITE STEM WAS BROKEN AND PARTIAL OF THE STEM WAS FOUND INSIDE THE FEMALE LUER LOCK ADAPTER. SOLVENT BOND BETWEEN THE INJECTION SITE AND FEMALE LUER LOCK ADAPTER WAS PRESENT. NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) REGARDING THE CATHETER EXT SET MICOBORE 2 ADAPTER Y-JUNCTION IN WHICH A BLOOD LEAK WAS OBSERVED DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY. 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

    Patients

    Seq Age Sex Outcome Treatment
    1