BEUDAMED
    FDA Adverse Event Other Summary report: N

    UMBILICAL ARTERY CATHETER

    MDR report key: 541226 · Received March 18, 2004

    Report

    Report Number
    9612233-2004-00004
    Event Type
    Other
    Date Received
    March 18, 2004
    Date of Event
    January 1, 2004
    Report Date
    March 12, 2004
    Manufacturer
    DIAMETRICS MEDICAL, LTD.
    Product Code
    FOS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PLACEMENT OF A DIAMETRICS MEDICAL LIMITED 3.7FR UMBILICAL ARTERY CATHETER (UAC) INTO AN INFANT, RESULTED IN UMBILICAL ARTERY PERFORATION. THIS INCIDENT WAS RECOGNIZED IMMEDIATELY DURING THE INSERTION PROCEDURE AND THE CATHETER WAS REMOVED. NO SIGNIFICANT COMPLICATIONS RESULTED FROM THE PERFORATION, WHICH INCLUDED: NO SEPSIS, NO SIGNIFICANT BLOOD LOSS, NO PERITONITIS, AND NO CARDIOPULMONARY EVENTS. THE CHILD SURVIVED AND WAS DISCHARGED FROM BOTH THE NICU AND THE HOSPITAL WITHOUT THE NEED FOR MEDICAL OR SURGICAL TREATMENT OF THIS IATROGENIC COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UMBILICAL ARTERY CATHETER UMBILICAL ARTERY CATHETER FOS DIAMETRICS MEDICAL, LTD. UAC 7001-3.7 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other