BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARTRIDGE, 3ML RG MEDICATION

    MDR report key: 13810624 · Received March 17, 2022

    Report

    Report Number
    MW5108283
    Event Type
    Malfunction
    Date Received
    March 17, 2022
    Date of Event
    January 8, 2022
    Report Date
    January 8, 2022
    Manufacturer
    CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD
    Product Code
    MRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IN, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    INBOUND. PATIENT REPORTING LOW CARTRIDGE ALARMS WITH CADD MS3, LOT NUMBER FOR CARTRIDGE (10)210729 AND TUBING LOT#4122813, NO FURTHER DETAILS PROVIDED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545097 CARTRIDGE, 3ML RG MEDICATION ACCESSORIES, PUMP, INFUSION MRZ CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD 4122813
    545098 CARTRIDGE, 3ML RG MEDICATION ACCESSORIES, PUMP, INFUSION MRZ CHENGDU SHIFENG MEDICAL TECHNOLOGY CO.,LTD (10)210729

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female