BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIPORT 5.5 MM SHORT SECONDARY PORT

    MDR report key: 1901083 · Received November 10, 2010

    Report

    Report Number
    2647580-2010-00882
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 13, 2010
    Manufacturer
    USSC PUERTO RICO
    Product Code
    GCJ
    PMA / PMN Number
    K981941
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UNKNOWN. ACCORDING TO THE REPORTER: ONCE THE DEVICE WAS INSERTED AND THEN REMOVED, AIR LEAKAGE OCCURRED. THERE IS SLIT ON SEAL. THERE WAS NO REPORT OF PIECES FALLING INTO THE CAVITY OR IMPACTING THE PATIENT. THE OPERATING TIME AND INCISION WERE NOT EXTENDED AS A RESULT. A NEW INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT INFO AVAILABLE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIPORT 5.5 MM SHORT SECONDARY PORT DISPOSABLE SURGICAL ACCESS DEVICE GCJ USSC PUERTO RICO P9K0305

    Patients

    Seq Age Sex Outcome Treatment
    1