BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1ST PICC S/L 26GA 1.9F X50CM

    MDR report key: 3779708 · Received April 16, 2014

    Report

    Report Number
    1625425-2014-00013
    Event Type
    Injury
    Date Received
    April 16, 2014
    Date of Event
    March 18, 2014
    Report Date
    April 16, 2014
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFORMATION REVEALED, THE PATIENT HAD A PICC LINE WHICH WAS INFUSION TPN/LIPIDS. THE PATIENT EXHIBITED SIGNS OF RESPIRATORY DISTRESS AND A CHEST X-RAY REVEALED THAT THE TIP WAS IN THE PLEURAL CAVITY. THE PICC LINE WAS DISCONTINUED AND LIPIDS WERE WITHDRAWN FROM THE PATIENT'S PLEURAL CAVITY. A PIV (PERIPHERAL IV) WAS PLACED FOR REMAINDER OF THE PATIENT'S INFUSION THERAPY. ANALYSIS OF THE RETURNED COMPLAINT SAMPLE SHOWED NO ABNORMALITIES OR DEFECTS. A PRESSURIZED FLUID LEAK TEST WAS PERFORMED AND NO LEAKS WERE DETECTED. THE RETURNED SAMPLE WAS FOUND TO BE FUNCTIONAL. CATHETERS ARE 100 PERCENT INSPECTED AT VARIOUS STAGES DURING THE MANUFACTURING PROCESS. A PRESSURE TEST IS PERFORMED ON ALL CATHETERS DURING MANUFACTURING TO ENSURE THE CATHETERS CAN WITHSTAND THE PRESSURE AND FORCES WHEN UTILIZED WITHIN THE INSTRUCTIONS FOR USE. A CONTROL PULL TEST IS ALSO PERFORMED PER THE SPECIFICATIONS. ACCORDING TO THE IFU, PICC CATHETERS SHALL HAVE THE DISTAL TIP SWELLING IN THE LOWER ONE THIRD OF THE SUPERIOR VENA CAVA TO THE JUNCTION OF THE SUPERIOR VENA AND THE RIGHT ATRIUM. HOWEVER, AS INDICATED IN THE REPORT THE PICC TIP WAS IN THE PLEURAL CAVITY WHICH COULD CAUSE RESPIRATORY DISTRESS. THE IFU STATES THAT FOR PROPER USE, CLINICIANS MUST BE FAMILIAR WITH AND TRAINED IN THE PLACEMENT, MAINTENANCE, AND USE OF PICC CATHETERS. THE IFU HAS INSTRUCTIONS FOR VERIFICATION OF PROPER PLACEMENT OF THE CATHETER. THE IFU ALSO STATES THAT THE EXTERNAL PORTION OF THE CATHETER MUST BE ADEQUATELY SECURED. THE ISSUE REPORTED IN THIS COMPLAINT WAS DUE TO IMPROPER PLACEMENT OF THE CATHETER OR IMPROPER SECUREMENT OF THE CATHETER WHICH COULD RESULT IN CATHETER MIGRATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXHIBITED SIGNS OF RESPIRATORY DISTRESS AND A CHEST X-RAY REVEALED THAT THE TIP WAS IN PLEURAL CAVITY. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED TO PREVENT IMPAIRMENT DAMAGE OR INJURY TO THE PATIENT. (CATHETER MIGRATION, PLEURAL EFFUSION). THE RN REMOVED THE CATHETER. IT WAS NOT REPORTED HOW MUCH EXCESS FLUID WAS REMOVED BETWEEN THE TWO PLEURAL LAYER DUE TO THE PLEURAL EFFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    233957 1ST PICC S/L 26GA 1.9F X50CM FIRST PICC FOZ ARGON MEDICAL DEVICES INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention