BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 6111863 · Received November 17, 2016

    Report

    Report Number
    2936999-2016-00961
    Event Type
    Injury
    Date Received
    November 17, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 24, 2016
    Manufacturer
    HENEQUEN-RX
    Product Code
    BTR
    PMA / PMN Number
    K090352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION (ID, AGE, SEX, WEIGHT) AS WELL AS ADDITIONAL INFORMATION ASSOCIATED WITH THE COMPLAINT HAVE BEEN REQUESTED AND IS EITHER UNKNOWN, WILL NOT BE MADE AVAILABLE TO MEDTRONIC, OR WILL BE PROVIDED AND UPDATED IN A SUPPLEMENTAL REPORT. THE CUSTOMER DID NOT RETAIN THE LOT NUMBER WHICH DETERMINES THE DATE OF MANUFACTURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE FAILURE MODE, CUFF WON¿T INFLATE, WAS CONFIRMED. ALL MANUFACTURING CONTROLS WERE FOUND ACCEPTABLE AND EFFECTIVE TO DETECT THE REPORTED FAILURE MODE. THE CONFIRMED FAILURE (LEAK IN CUFF) WOULD HAVE BEEN DETECTED DURING THE 100 PERCENT INFLATION/DEFLATION TEST. THE CUT IN CUFF CONDITION FOUND IN THE RECEIVED SAMPLE IS NOT CONFIRMED AS RELATED TO MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    DURING USE THE CUFF DID NOT INFLATE. THE TUBE WAS REMOVED AND REPLACED. THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762677 MALLINCKRODT TAPERGUARD EVAC TRACHEAL 7.5 BTR HENEQUEN-RX 18875

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention