BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ANGIOCATH

    MDR report key: 370675 · Received January 7, 2002

    Report

    Report Number
    MW1023779
    Event Type
    Malfunction
    Date Received
    January 7, 2002
    Date of Event
    December 17, 2001
    Report Date
    December 20, 2001
    Manufacturer
    BD MEDICAL SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BD PRODUCT INSYTE AUTOGUARD WINGED, LEAKED AT HUB AFTER INSERTION. TRIED SEVERAL DIFFERENT J-LOOPS TO DETERMINE THAT THE ANGIOCATH WAS THE PRODUCT THAT WAS LEAKING. WOULD NOT SEAL EVEN WITH TIGHTENING. CONFIRMED BY RN TIGHTENING AND NURSE MGR CHECKING. REQUIRED PRODUCT TO BE DISCONTINUED AND PT TO HAVE ANOTHER IV START.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD ANGIOCATH INSYTE AUTOGUARD WINGED ANGIOCATH FOZ BD MEDICAL SYSTEMS * 107051

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other