BEUDAMED
    FDA Adverse Event Other Summary report: N

    L-CATH PICC KIT WITH SPLITTABLE NEEDLE INTRO.

    MDR report key: 2087907 · Received May 3, 2011

    Report

    Report Number
    1625425-2011-00069
    Event Type
    Other
    Date Received
    May 3, 2011
    Date of Event
    April 12, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    LJS
    PMA / PMN Number
    K920755
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FAILURE COULD NOT BE VERIFIED DUE TO NO PRODUCT BEING RETURNED FOR EVAL. A ROOT CAUSE IS UNABLE TO BE DETERMINED; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    PICC LINE PLACED VIA LEFT SAPHENOUS VEIN AND THREADED TO 22CM. X-RAY OBTAINED FOR TIP PLACEMENT SHOWED IT HAD COILED IN THE PERITONEAL CAVITY AND WAS NOT IN A VASCULAR SPACE. CATHETER REMOVED, AND X-RAY DONE. THERE WAS NO FREE AIR. SIX HOURS LATER, THE INFANT HAD A CHANGE IN CONDITION AND A SEPTIC WORK UP WAS DONE. BLOOD CULTURE GROWING RESISTANT STRAIN OF (B)(6), BUT THIS ORGANISM WAS ALSO GROWING FROM AN ABDOMINAL WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PICC KIT WITH SPLITTABLE NEEDLE INTRO. LJS ARGON MEDICAL DEVICES, INC. NA 9236001

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Other