BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPICC

    MDR report key: 5567116 · Received April 11, 2016

    Report

    Report Number
    5567116
    Event Type
    Malfunction
    Date Received
    April 11, 2016
    Date of Event
    November 10, 2015
    Report Date
    April 4, 2016
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    MEDICAL COMPONENTS, INC. 4 FRENCH SINGLE LUMEN PRO PICC KIT OPENED BY CRNA AND DISCOVERED THAT THE LIDOCAINE VIAL WAS BROKEN, EMPTY, AND THE INSIDE KIT WAS DRY. GAUZE 4X4 ON TOP OF THE PACK WAS USED TO WIPE/PREP PATIENT SITE AFTER CHLORAPREP USED AFTER DRAPING PATIENT WITH DRAPES. NEXT STEP TO DRAW UP LIDOCAINE; DISCOVERED NECK OF VIAL WAS BROKEN AND NO LIQUID PRESENT. THEN DISCOVERED KIT SCALPEL WAS RUSTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222671 PROPICC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM LJS MEDICAL COMPONENTS, INC. MRCTP41001 MBYT430

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR