BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER

    MDR report key: 1339376 · Received March 9, 2009

    Report

    Report Number
    1710034-2009-00040
    Event Type
    Other
    Date Received
    March 9, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 17, 2009
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED ON 20 FEBRUARY 2009 AND IS CURRENTLY BEING DE CONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CATHETER WAS INSERTED IN RIGHT HAND ON (B)(6)2009. THE CATHETER WAS REPAIRED AND TRIMMED AT 29 CM FROM HUB. THE CATHETER WAS REMOVED ON (B)(6)2009. ON (B)(6)2009, THE BABY EXPERIENCED A NUMBER OF ARRYTHMIAS. THEY DID X-RAYS BUT DID NOT SEE ANY CATHETER PARTICLES IN THE VENTRICLE. HOWEVER, THEY FELT THAT THE TIP OF THE CATHETER LOOKED "FUNNY" AND THAT THE MARKINGS ON THE CATHETER DIDN'T LOOK RIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER PERCUTANEOUS CATHETER LJS BECTON DICKINSON INFUSION THERAPY SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 1 MO Other