BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2924584 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01579
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K120443
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT REPRESENTS 2 OF 3 EVENTS REPORTED BY THE CUSTOMER. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CANNOT BE DETERMINED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER HEALTHCARE CORPORATE PRODUCT SURVEILLANCE ONE (1) ONE-LINK NON-DEHP MICROBORE CATHETER EXTENSION SET IN WHICH AN UNSPECIFIED SYRINGE BECAME SEPARATED FROM THE DEVICE DURING PATIENT USE. THE CUSTOMER OBSERVED THAT THE SYRINGE HAS TO BE "STRAIGHT ON" WHEN CONNECTING TO THE ONE-LINK TO ENSURE A SECURE CONNECTION. THERE IS PATIENT INVOLVEMENT; HOWEVER, THERE IS NO PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30807 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SYRINGE