BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERSAPORT 5MM FIXATION CANNULA

    MDR report key: 1993595 · Received January 24, 2011

    Report

    Report Number
    2647580-2011-00063
    Event Type
    Malfunction
    Date Received
    January 24, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 6, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K062326
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. PT GENDER: UNK. ACCORDING TO THE REPORTER: WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE, IT WAS NOTICED THAT THE TIP WAS BROKEN. THE DEVICE DID NOT COME IN CONTACT WITH THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPORT 5MM FIXATION CANNULA DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0L0625

    Patients

    Seq Age Sex Outcome Treatment
    1