BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4862494 · Received June 23, 2015

    Report

    Report Number
    1416980-2015-26274
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    April 22, 2015
    Report Date
    June 2, 2015
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE DEVICE HAD SEALED TUBING. THE REPORTED CONDITION WAS VERIFIED. A BATCH REVIEW WAS PERFORMED AND REVEALED THAT THE DEVICE WAS PACKAGED ON A NEW PACKAGING MACHINE. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE IMPROPER PACKAGING. THE DEVICE WAS CAUGHT IN THE POUCH SEAL ON A MANUAL PACKAGING MACHINE. A CAPA HAS BEEN OPENED TO ADDRESS THIS ISSUE. MACHINE OPERATORS WERE MADE AWARE OF THE ISSUE, AND A MECHANISM THAT DETECTS TUBES CAUGHT BY THE POUCH SEAL WAS INSTALLED ON THE PACKAGING MACHINE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HOLE IN A CONTINU FLO SET. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406392 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 14L22V924

    Patients

    Seq Age Sex Outcome Treatment
    1