BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MALLINCKRODT

    MDR report key: 6039592 · Received October 19, 2016

    Report

    Report Number
    2936999-2016-00864
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 27, 2016
    Manufacturer
    HENEQUEN-RX
    Product Code
    BTR
    PMA / PMN Number
    K151381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PATIENT INFORMATION 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING RE-INTUBATION THE NURSE NOTICED THAT THE MARKS ON THE BREATHING TUBE WERE ERASED AND NOT VISIBLE. THE PROCEDURE TIME WAS EXTENDED AND LEAD TO A BRADYCARDIA TO THE CHILD. THE DEVICE IS STILL ON THE PATIENT AND ANY TYPE OF INTERVENTION WAS NOT REPORTED. THE PATIENT WAS A NEW BORN BABY BOY - (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693089 MALLINCKRODT BT 3.0 MM CFLS MURPHY NON DEHP BTR HENEQUEN-RX 86234 16A0204JZX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention