BEUDAMED
    FDA Adverse Event Summary report: N

    FIRST PICC S/L 26G (1.9F) X 50CM

    MDR report key: 6146827 · Received December 6, 2016

    Report

    Report Number
    8020616-2016-00027
    Date Received
    December 6, 2016
    Date of Event
    July 11, 2016
    Report Date
    December 6, 2016
    Manufacturer
    ARGON MEDICAL DEVICES, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K972262
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN CONDUCTED AND A SUMMARY OF FINDINGS IS PROVIDED BELOW: A REVIEW OF THE BATCH DOCUMENTATION, WHICH INCLUDES DEVICE HISTORY RECORDS AND INSPECTION REPORTS, SHOWED NO NON-CONFORMANCE IN THE VISUAL AND FUNCTIONAL INSPECTION OF THE AFFECTED FIRST PICC CATHETER DURING THE MANUFACTURING. FROM THIS BATCH RECORDS REVIEW WE CONFIRMED THAT ALL THE OPERATIONS, MATERIALS AND TESTING WERE PROPERLY PERFORMED ON THE DEVICE AND THE TEST RESULTS SHOWED NO FAILURES OR INDICATION OF POTENTIAL PROBLEM RELATED TO THE REPORTED FAILURE OF THE FIRST PICC ASSEMBLY. VISUAL EXAMINATION WAS CONDUCTED ON THE USED DEVICE OBSERVED THAT THE SINGLE LUMEN SILICON CATHETER TUBE WAS SEPARATED (AT APPROXIMATELY 2MM FROM THE NOSE-TIP) UPON RECEIPT. THE EDGES OF THE SEPARATED TUBING ENDS WERE OVAL-SLANTED, CLEAN, SMOOTH SURFACES INDICATING THAT THE BROKEN CATHETER WAS UNLIKELY CAUSE BY MATERIAL DEFECTS OR BEING STRETCHED UNTIL SNAPPED OFF. THE DEFECT COULD DUE TO MISHANDLING OF PRODUCT DURING APPLICATION. BASED ON THE ABOVE ANALYSIS, THE DEFECT COULD HAVE OCCURRED OUTSIDE THE MANUFACTURING PLANT AND DURING PRODUCT APPLICATION. DAMAGED TUBING CAN BE DETECTED DURING THE VISUAL INSPECTION AND FUNCTIONAL TEST DURING THE MANUFACTURING PROCESSES. ON THE PROFILE OF THE BROKEN EDGES ON BOTH TUBING ENDS OF THE COMPLAINT SAMPLE, IT CAN ALSO BE CONCLUDED THAT THE DEFECT IS NOT LIKELY DUE TO MATERIAL ISSUE AND IS MORE LIKELY DUE TO PRODUCT HANDLING DURING PRODUCT APPLICATION. NO CORRECTIVE ACTION IS TRIGGERED FOR THE REPORTED ISSUE AS THE DEFECT IS LIKELY ATTRIBUTED OUTSIDE THE MANUFACTURING PLANT.

    Description of Event or Problem · 1

    BREAKAGE OF THE CATHETER A FEW HOURS AFTER PUT IN PLACE. BREAKAGE UNDER THE TEGADERM DRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    799800 FIRST PICC S/L 26G (1.9F) X 50CM PERIPHERALLY-INSERTED CENTRAL VENOUS CATHETER FOZ ARGON MEDICAL DEVICES, INC. 601018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other