BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2467623 · Received February 24, 2012

    Report

    Report Number
    6000001-2012-05818
    Event Type
    Malfunction
    Date Received
    February 24, 2012
    Date of Event
    September 29, 2011
    Report Date
    October 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER RETURNED THE ACTUAL SAMPLE FOR EVALUATION. THE SAMPLE WAS VISUALLY AND FUNCTIONALLY TESTED AND THE REPORTED CONDITION WAS NOT CONFIRMED. A THREAD INTERFACE FUNCTIONAL TEST WAS CONDUCTED ON THE RETURNED SAMPLE WITH A (B)(4) THREAD LOCK CANNULA AND NO DEFECT WAS OBSERVED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. NO ASSIGNABLE ROOT CAUSE COULD BE DETERMINED. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510 NUMBER

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) REGARDING THE INTERLINK INJECTION SITE IN WHICH THE CONNECTION BETWEEN THE INJECTION SITE AND THE THREADED LOCK CANNULA BECAME LOOSE DURING SET-UP. IT IS UNKNOWN IN WHICH CARE AREA THIS EVENT OCCURRED. THERE IS NO PATIENT INVOLVEMENT AND 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