BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3113426 · Received May 15, 2013

    Report

    Report Number
    1416980-2013-12351
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Report Date
    April 22, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K811078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. A BATCH REVIEW WAS CONDUCTED AND REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. SHOULD THE DEVICE AND/OR ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A Y-TYPE CATHETER EXTENSION SET (STERILE PACKAGE) WHERE "THE CAP DISCONNECTS VERY EASILY FROM THE Y-SITE." IT IS UNKNOWN WHERE IN THE PROCESS THIS OCCURRED. PATIENT INVOLVEMENT IS UNKNOWN AT THIS TIME. NO INJURY OR ADVERSE EVENT IS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214176 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13A29069

    Patients

    Seq Age Sex Outcome Treatment
    1