BEUDAMED
    FDA Adverse Event Summary report: N

    L-CATH PICC 26G (1.9F) 0.60MM X 30CM

    MDR report key: 6141207 · Received December 2, 2016

    Report

    Report Number
    1625425-2016-00092
    Date Received
    December 2, 2016
    Date of Event
    November 2, 2016
    Report Date
    December 2, 2016
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K091670
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. BASED ON THE EVENT DESCRIPTION, IT IS UNCLEAR WHERE THE FLUID INFILTRATION OCCURRED. ADDITIONAL INFORMATION FROM THE CUSTOMER DESCRIBED FLUID LEAKING INTO THE CHEST NECESSITATING A CHEST TUBE AND FLUID LEAKING INTO THE ABDOMINAL CAVITY NECESSITATING FLUID ASPIRATION. BECAUSE A DECOMPENSATED RESPIRATORY STATUS WAS DESCRIBED, IT IS POSSIBLE THAT PLEURAL EFFUSION IS THE PHENOMENON BEING DESCRIBED. AS THE PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, A CATHETER MALFUNCTION COULD NOT BE CONFIRMED. POTENTIAL CAUSES OF PLEURAL EFFUSION INCLUDE TRAUMA TO THE VEIN DUE TO CONTACT WITH THE CATHETER TIP, PERFORATION OF THE VEINS UPON INSERTION, OR THE PICC TIP BEING OUTSIDE OF THE SUPERIOR VENA CAVA. THESE OCCURRENCES MAY BE CAUSED BY THE INITIAL CATHETER PLACEMENT LOCATION AS WELL AS CATHETER MIGRATION (WHICH CAN BE RELATED TO CATHETER SECUREMENT, PATIENT MOVEMENT, AND INITIAL CATHETER PLACEMENT). FIRST PICC CATHETERS ARE 100% IN-PROCESS INSPECTED AT VARIOUS TIMES DURING MANUFACTURE. CATHETERS ARE ALSO LEAK, FLOW, AND BURST TESTED TO ENSURE THEIR INTEGRITY.

    Description of Event or Problem · 1

    TPN/LIPDS (IV FLUIDS) THAT WERE BEING INFUSED THROUGH THE PICC LINE WERE LEAKING INTO THE ABDOMINAL CAVITY. INFANT HAD TO HAVE MULTIPLE X-RAYS / ULTRASOUNDS AND THE FLUID HAD TO BE ASPIRATED FROM THE ABDOMINAL CAVITY. THE ISSUE REQUIRED PATIENT TO HAVE A CHEST TUBE PLACED AND PATIENT HAD DECOMPENSATED RESPIRATORY STATUS UNTIL INFILTRATION WAS REVERSED. PICC INSERTION SITE WAS THE RIGHT SAPHENOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791204 L-CATH PICC 26G (1.9F) 0.60MM X 30CM L-CATH PICC FOZ ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention