BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5.5MM SHORT SECONDARY PORT

    MDR report key: 4133529 · Received October 1, 2014

    Report

    Report Number
    9612501-2014-00343
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP REPORT SENT TO FDA ON 04/02/2015.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER: AFTER INSERTION OF THE PEDI PORT UPON OPENING OF THE FIXATION CAGE A PIECE OF PLASTIC WAS OBSERVED TO SNAP OFF FROM THE PORT. MR (B)(6) NOTICED THE PIECE OF PLASTIC AND RETRIEVED IT. THE PLASTIC PIECE WAS REPORTED TO HAVE BEEN RETRIEVED FROM WITHIN THE PATIENT AND THE PROCEDURE CONTINUED ON AS PLANNED. IT WAS ALSO REPORTED THAT THE MECHANISM FOR OPENING AND CLOSING THE FIXATION CAGE ON THE END OF THE PORT SEEMS TO HAVE ALSO FAILED DURING THE OPENING PROCESS, HOWEVER IT WAS REPORTED THAT MR (B)(6) WAS STILL ABLE TO OPEN THE FIXATION CAGE TO REMOVE THE PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613297 5.5MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN 24055

    Patients

    Seq Age Sex Outcome Treatment
    1