BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE TIP CLEANER

    MDR report key: 4935626 · Received July 17, 2015

    Report

    Report Number
    1836161-2015-00069
    Event Type
    Malfunction
    Date Received
    July 17, 2015
    Date of Event
    June 5, 2015
    Report Date
    July 17, 2015
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    KXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REJECTED 1 PIECE DUE TO PACKING FAILURE. STERILE BARRIER BREACH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467339 STERILE TIP CLEANER STERILE TIP CLEANER KXG ASPEN SURGICAL PRODUCTS, INC. TC-100B 69117

    Patients

    Seq Age Sex Outcome Treatment
    1