BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 2024069 · Received March 11, 2011

    Report

    Report Number
    2647580-2011-00168
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 16, 2011
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNK. ACCORDING TO THE REPORTER: WHEN INSERTED THE SPIKE TUBE INTO CANNULA, THE INNER SEALS BROKE. NOT USED FOR PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P0L0708

    Patients

    Seq Age Sex Outcome Treatment
    1