BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLUNTPORT* BLUNT TROCAR W/ THREADED ANCHOR

    MDR report key: 4844296 · Received June 15, 2015

    Report

    Report Number
    9612501-2015-00311
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    June 2, 2015
    Report Date
    June 3, 2015
    Manufacturer
    COVIDIEN
    Product Code
    GCJ
    PMA / PMN Number
    K142547
    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

    ADDITIONAL INFORMATION PROVIDED BY THE ACCOUNT: OBTURATOR PART WAS BEING BROKEN.

    Description of Event or Problem · 1

    PROCEDURE: LADG. ACCORDING TO THE REPORTER: WHEN OPENING THE PACKAGE, ITS INNER SLEEVE WAS BEING BROKEN. THIS IS A SAMPLE DEVICE. NOT USED FOR A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388221 BLUNTPORT* BLUNT TROCAR W/ THREADED ANCHOR DISPOSABLE SURGICAL ACCESS DEVICE GCJ COVIDIEN BPT12STS J5B0490X

    Patients

    Seq Age Sex Outcome Treatment
    1