BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE OPEN HEART 2PART PACK- PACK A

    MDR report key: 8378170 · Received February 27, 2019

    Report

    Report Number
    MW5084488
    Event Type
    Malfunction
    Date Received
    February 27, 2019
    Report Date
    February 21, 2019
    Manufacturer
    MEDLINE INDUSTRIES, INC SPT
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SEVERAL OCCURRENCES OF BRAND NEW OPEN HEART PACKS (A) HAVING LARGE YELLOW SPOTS ON LAP SPONGES. MEDLINE AND COVIDIEN REPS CANNOT AGREE ON WHO IS AT FAULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165999 MEDLINE OPEN HEART 2PART PACK- PACK A CARDIOVASCULAR PROCEDURE KIT OEZ MEDLINE INDUSTRIES, INC SPT 18HBP757
    166000 MEDLINE OPEN HEART 2PART PACK- PACK A CARDIOVASCULAR PROCEDURE KIT OEZ MEDLINE INDUSTRIES, INC. SPT 18KBS199

    Patients

    Seq Age Sex Outcome Treatment
    1