BEUDAMED
    FDA Adverse Event Death Summary report: N

    UMBILICAL CATHETER

    MDR report key: 5520997 · Received March 23, 2016

    Report

    Report Number
    2245270-2016-00007
    Event Type
    Death
    Date Received
    March 23, 2016
    Date of Event
    February 25, 2016
    Report Date
    March 23, 2016
    Manufacturer
    VYGON SA
    Product Code
    FOS
    PMA / PMN Number
    K851005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION RESULT: THE CATHETER WORKS CORRECTLY 3 DAYS AFTER PLACEMENT. THE X-RAY CONTROLS SHOWS NO CATHETER'S ANOMALY. WE HAVE ANALYZED THE INVOLVED CATHETER. THE CATHETER IS NOT DAMAGED. WE NOTICED NO CATHETER LEAKAGE. ITS TIP AND THE DIMENSION ARE COMPLIANT. DURING THE MANUFACTURING PROCESS A 100% TIGHTNESS CONTROL IS PERFORMED ON EACH UMBILICAL CATHETER PRIOR PACKING. THIS CONFIRMED THE X-RAY CONTROL; NO CATHETER'S ANOMALY HAS BEEN DETECTED. AS NO POST MORTEM EXAMINATION HAS BEEN DONE, WE COULD NOT KNOWN IF ANY PERFORATION OCCURRED.

    Description of Event or Problem · 1

    AN UMBILICAL CATHETER HAS BEEN INSERTED ON A PREMATURE BABY (B)(6) JUST AFTER HIS BIRTH ON (B)(6) 2016. THE INSERTION OF UMBILICAL CATHETER AND THE LOCATION WERE CORRECT; THE CENTRAL POSITION HAS BEEN CHECKED BY X-RAY CONTROL . THE ADMINISTRATION OF INFUSION HAS BEEN DONE UNTIL (B)(6) WITHOUT ANY PROBLEM. ON (B)(6), THE BABY'S HEALTH DETERIORATES, A PERITONEAL EFFUSION IS DETECTED. THE LOCATION OF THE CATHETER IS CHECKED , IT STAYS IN THE CENTRAL POSITION . THE PATRICIAN REMOVED IT FROM 2CM, NO IMPROVEMENT OF BABY'S HEALTH. THE BABY IS SHOCKED AND HE DIED ON (B)(6). THE DEATH SEEMS NOT TO BE LINKED TO THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176011 UMBILICAL CATHETER UMBILICAL CATHETER FOS VYGON SA 090415FP

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death