BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROBORE EXTENSION SET, 60IN

    MDR report key: 6028173 · Received October 13, 2016

    Report

    Report Number
    9612030-2016-00522
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Report Date
    October 12, 2016
    Manufacturer
    COVIDIEN
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/13/2016. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE PRODUCTION OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. THERE WERE NO SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION, A ROOT CAUSE ANALYSIS COULD NOT BE CONDUCTED TO DETERMINE THE ROOT CAUSE OF THIS REPORTED ISSUE. IF SAMPLES ARE RECEIVED AT A LATER DATE, THIS COMPLAINT WILL BE RE-OPENED AND THE INVESTIGATION CONTINUED. THE MANUFACTURING PERSONNEL INVOLVED IN THE PROCESS WERE NOTIFIED OF THE REPORTED CONDITION. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2016 THAT A CUSTOMER HAD AN ISSUE WITH AN EXTENSION SET. THE CUSTOMER STATES THAT THE ITEM WAS LEAKING AT THE PURPLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678271 MICROBORE EXTENSION SET, 60IN EXTENSION SET FPA COVIDIEN 60ES 6144680764X

    Patients

    Seq Age Sex Outcome Treatment
    1