BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENALIN PR TEST SYSTEM PACKET

    MDR report key: 6510741 · Received April 18, 2017

    Report

    Report Number
    MW5069232
    Event Type
    Malfunction
    Date Received
    April 18, 2017
    Date of Event
    April 18, 2017
    Report Date
    April 18, 2017
    Manufacturer
    MINNTECH/MEDIVATOR
    Product Code
    LIF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE LOT NUMBER AND EXPIRATION DATE OF RENALIN PR TEST SYSTEM PACKET ON THE OUTER BAG IS NOT CONSISTENT WITH THE LOT NUMBER AND EXPIRATION OF THE VIAL. EXAMPLE 1: LOT # AND EXPIRATION ON BAG = 789574, 04/2017- LOT # AND EXPIRATION IN VIALS = 796464; 06/2017 (VIAL 1), 793681, 05/2017 (VIAL 2) PRODUCTS WERE NOT OPENED OR USED EXAMPLE 2: LOT # AND EXPIRATION ON BAG = 790182; 04/2017- LOT # AND EXPIRATION IN VIALS = 789573; 05/2017 (VIAL 1), 787110; 04/2017 (VIAL 2). RENALIN PR TEST SYSTEM PACKET PRODUCTS WERE NOT OPENED OR USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283143 RENALIN PR TEST SYSTEM PACKET RENALIN PR TEST SYSTEM PACKET LIF MINNTECH/MEDIVATOR 789573
    283144 RENALIN PR TEST SYSTEM PACKET RENALIN PR TEST SYSTEM PACKET LIF MINNTECH/MEDIVATOR 787110

    Patients

    Seq Age Sex Outcome Treatment
    1 RENALIN PR TEST SYSTEM PACKET PRODUCTS WERE NOT,