BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE INDUSTRIES, INC.

    MDR report key: 6325325 · Received February 13, 2017

    Report

    Report Number
    6325325
    Event Type
    Malfunction
    Date Received
    February 13, 2017
    Date of Event
    December 29, 2016
    Report Date
    January 18, 2017
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO AV FISTULA PACKS WERE DISCOVERED TO HAVE CONTAMINANTS IN THE PACK UPON OPENING THEM. THESE EVENTS WERE NOT NECESSARILY FROM THE SAME SURGICAL CASE. THEY WERE REPORTED TO CLINICAL ENGINEERING FROM AN OSF (OUTSIDE FACILITY). THE PACKAGING WAS SAVED FROM EACH OF THE PACKS AND A NEW PACK WAS OPENED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107895 MEDLINE INDUSTRIES, INC. GENERAL SURGERY TRAY LRO MEDLINE INDUSTRIES, INC. DYNJ51804A 16SB8811

    Patients

    Seq Age Sex Outcome Treatment
    1