BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MONOJECT

    MDR report key: 19102960 · Received April 14, 2024

    Report

    Report Number
    3005670221-2024-00004
    Event Type
    Malfunction
    Date Received
    April 14, 2024
    Report Date
    April 14, 2024
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD
    Product Code
    PNR
    UDI-DI
    06971564466240
    PMA / PMN Number
    K190502
    Removal / Correction Number
    Z-0849-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    3RETURNED SAMPLE WAS REQUESTED BUT HAVEN'T RECEIVED YET. THE DHR OF THIS LOT WAS REVIEWED WITHOUT ANY ISSUE. THE DESIGN HISTORY FILE AND 510K SUMBSSION WERE REVIEWED. THIS SYRINGE IS DESIGNED FOR MANUAL USE ONLY, NOT FOR PUMP USE. FOR MANUAL USE OR NOT FOR PUMP USE WAS NOT PRESENTED ON ANY LABELING OF THIS PRODUCT. THE COMPLIANT HISTORY WAS REVIEW ONE PUMP COMPATBILITY ISSUES WITH THIS PRODUCT WERE RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0849-2024. THE CORRETIVE ACTION PUTTING THE CAUTION "FOR MANUAL USE OR NOT FOR PUMP USE" ON ALL ENTERAL SYRINGES' LABELING OF K190502 WILL BE TAKEN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION FROM THE RECEIVED SAMPLES.

    Description of Event or Problem · 0

    THE SYRINGE CAN'T BE USED WITH THE FEEDING PUMPS, THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832549 MONOJECT ENFIT ENTERAL SYRINGE PNR JIANGSU CAINA MEDICAL CO., LTD 230602 06971564466240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other