BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 6716146 · Received July 14, 2017

    Report

    Report Number
    8020889-2017-05074
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 20, 2017
    Report Date
    August 19, 2017
    Manufacturer
    MALLINCKRODT MEDICAL
    Product Code
    BTS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US - 510(K) NUMBER K771219. 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

    THE SAMPLE WAS RECEIVED FOR ANALYSIS AND THE REPORTED ISSUE WAS CONFIRMED. A INFLATION/DEFLATION TEST WAS PERFORMED AND THE BRONCHIAL CUFF INFLATED WITHOUT ANY ISSUE HOWEVER THE TRACHEAL CUFF WOULD NOT INFLATE. A VISUAL INSPECTION WAS PERFORMED AND A SLIT IN THE MAIN BODY OF THE TRACHEAL CUFF WAS OBSERVED. THE SINGLE WALL THICKNESS OF THE TRACHEAL CUFF WAS MEASURED AWAY FROM THE DAMAGED AREA AND FOUND TO BE WITHIN THE BLUEPRINT SPECIFICATION. THE DAMAGE DETECTED IS INDICATIVE OF CONTACT WITH A SHARP UTENSIL OR OBJECT. MANUFACTURING CONTROLS ARE IN PLACE TO DETECT CUFFS WITH DAMAGE AND TO REDUCE THE POTENTIAL FOR OCCURRENCE DURING THE MANUFACTURING PROCESS. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THE GAS COLD NOT BE WITHDRAWN FROM THE BRONCHIAL CATHETER. CUSTOMER STATED THERE WAS NO PATIENT INJURY WITH THIS EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THE GAS COLD NOT BE WITHDRAWN FROM THE BRONCHIAL CATHETER. CUSTOMER STATED THERE WAS NO PATIENT INJURY WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494331 MALLINCKRODT TUBE, BRONCHIAL (W/WO CONNECTOR) BTS MALLINCKRODT MEDICAL 126-37 201610016X

    Patients

    Seq Age Sex Outcome Treatment
    1