BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICAL ACTION INDUSTRIES

    MDR report key: 8990725 · Received September 11, 2019

    Report

    Report Number
    8990725
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 14, 2019
    Report Date
    August 21, 2019
    Manufacturer
    MEDICAL ACTION INDUSTRIES INC. 306
    Product Code
    PEZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MEDICAL ACTION INDUSTRIES INC. CVC REDRESS KIT RED #77433, LOT#260139, EXP 01-31-2021. CVC REDRESS KIT DID NOT HAVE A BIOBATCH, STERILE GLOVES WERE ABNORMALLY THIN AND EASY TO RIP, AND CHLORA-PREP SWABS WERE DRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784137 MEDICAL ACTION INDUSTRIES CENTRAL VENOUS CATHETER DRESSING CHANGE KIT PEZ MEDICAL ACTION INDUSTRIES INC. 306 77433 260139

    Patients

    Seq Age Sex Outcome Treatment
    1