BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120CM LINE 1200 PSI FLEX RA X1

    MDR report key: 2020407 · Received February 8, 2011

    Report

    Report Number
    8010719-2011-00001
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 12, 2011
    Manufacturer
    MEDTRON AG
    Product Code
    DRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION. UPON RECEIPT OF INVESTIGATION, A MEDWATCH 3500A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTS; "AT THE BEGINNING OF THE INJECTION, THE HIGH PRESSURE TUBE BREAKS AT THE TIP OF THE CONTRAST MEDIA SYRINGE: AT THE CONNECTION TO THE SYRINGE. CONTRAST MEDIA SOLUTRAST 370 WAS USED." NO PERSON INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 120CM LINE 1200 PSI FLEX RA X1 DISPOSABLE HIGH PRESSURE TUBING DRS MEDTRON AG FLEX120RA M038104

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK