BEUDAMED
    FDA Adverse Event Summary report: N

    FIRST PICC S/L 20G (3F) X 65CM)

    MDR report key: 4905952 · Received July 7, 2015

    Report

    Report Number
    1625425-2015-00028
    Date Received
    July 7, 2015
    Date of Event
    May 28, 2015
    Report Date
    July 6, 2015
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    FOZ
    PMA / PMN Number
    K944504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS MANUFACTURED AT ARGON (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS AND INSPECTION REPORTS, SHOWED THAT THE FIRST PICC KIT WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AND DOCUMENTED WORK PROCEDURES. BASED UPON A REVIEW OF THE RECORDS, IT WAS CONFIRMED THAT ALL OF THE OPERATIONS, MATERIALS, AND TESTING WERE PROPERLY PERFORMED ON THE DEVICES FROM THE AFFECTED LOT AND TEST RESULTS SHOWED NO FAILURES OR INDICATIONS OF A POTENTIAL PROBLEM RELATING TO THE STYLET. THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. AN UN-OPENED UNIT WITH THE STYLET AND CATHETER TUBING STILL IN THE PROTECTIVE SLEEVE WAS RETURNED FOR ANALYSIS. TESTING PERFORMED ON THE RETURNED SAMPLE INDICATED NO DEFECTS. BASED ON THE COMPLAINT DESCRIPTION AND AVAILABLE INFORMATION IN THE REPORTED INCIDENT, THE CAUSE OF COMPLAINT DESCRIBED ABOVE COULD NOT BE DETERMINED BECAUSE THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR INVESTIGATION. IN ADDITION, IT WAS NOT CONFIRMED IF THE ISSUE WAS WITH THE CATHETER TIP OR STYLET TIP. HOWEVER, THE POTENTIAL CONTRIBUTIONS TO THE FAILURE ARE: EXCESSIVE FRICTIONAL FORCES BETWEEN THE STYLET AND THE CATHETER LUMEN DUE TO THE BEND ON THE STYLET AND FAST REMOVAL OF THE STYLET CAUSING THE VEIN TO CONSTRICT.

    Description of Event or Problem · 1

    THE CATHETER WAS PLACED ON THE PATIENT WITHOUT TROUBLE BUT WHEN IT WAS TIME TO REMOVE THE GUIDEWIRE, IT WAS IMPOSSIBLE BECAUSE IT WAS STUCK AND THEY USE FORCE TO REMOVE IT. BUT A PIECE OF THE KT (FRENCH TERM FOR CATHETER) REMAINED INSIDE THE FOREARM OF THE PATIENT. THE PATIENT RECEIVED AND OPERATION TO REMOVE THIS LITTLE PIECE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439339 FIRST PICC S/L 20G (3F) X 65CM) FIRT PICC FOZ ARGON MEDICAL DEVICES INC. 412336

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention