BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8020889-2017-05011

    MDR report key: 6504374 · Received April 19, 2017

    Report

    Report Number
    8020889-2017-05011
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    March 16, 2017
    Report Date
    December 5, 2017
    Manufacturer
    COVIDIEN
    Product Code
    JOL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THERE WERE NO SAMPLES RETURNED FOR EVALUATION. THREE REPRESENTATIVE SAMPLES WERE TAKEN FROM STOCK LOT NUMBER 201710474X, PRODUCT PART NUMBER (B)(4). A VISUAL EXAMINATION OF THE SAMPLES SHOWS THAT THE CAP IS FULLY INTACT WITH NO SPLITS. THE REPORTED DEFECT COULD NOT BE DETECTED ON THE UNITS INSPECTED. IN THE ABSENCE OF THE ACTUAL COMPLAINT SAMPLE IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS PARTICULAR ISSUE. THE MOST PROBABLE ROOT CAUSE IS THE THORACIC CAP WAS ATTACHED TO A CONNECTOR WHICH WAS NOT COMPATIBLE WITH OUR PRODUCT. ALL OF THE THORACIC CAPS ARE MANUALLY APPLIED TO THE THORACIC CATHETERS AS PART OF THE MANUFACTURING PROCESS SO THAT ANY ISSUES CAN BE IDENTIFIED AND REMOVED FROM THE LOT THEREFORE NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE TIP OF THE CATHETER (BLUE PART) SPLIT AND CAUSED AN AIR LEAK WHICH CAUSED THE PATIENT TO BE HEMODYNAMICALLY COMPRISED AND REQUIRED INCREASED INOTROPIC SUPPORT. PNEUMOTHORAX OCCURRED WHICH LED TO TWO EXTRA DAYS OF HOSPITALIZATION. BECAUSE OF THE PNEUMOTHORAX, THE PATIENT REQUIRED INTERVENTION THAT WOULD OTHERWISE NOT HAVE OCCURRED, WHICH INCLUDED A LONGER STAY IN ICU. THE PATIENT IS CURRENTLY IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286984 JOL COVIDIEN 210-32

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization