BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19096290 · Received April 12, 2024

    Report

    Report Number
    3005670221-2024-00021
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Report Date
    April 12, 2024
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD.
    Product Code
    PNR
    UDI-DI
    06971564466202
    PMA / PMN Number
    K190502
    Removal / Correction Number
    Z-0858-2024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED 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 REVIEWED ONE PUMP COMPATBILITY ISSUE WITH THIS PRODUCT WAS RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0858-2024. THE CORRETIVE ACTION PUTTING THE CAUTION "FOR MANUAL USE OR NOT FOR PUMP USE" ON ALL SYRINGES' LABELING OF K190503 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 CUSTOMER REPORTED THAT THE SYRINGES CANNOT BE USED WITH THE FEEDING PUMPS. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413067 CARDINAL HEALTH ENFIF ENTERAL SYRINGE PNR JIANGSU CAINA MEDICAL CO., LTD. 230601 06971564466202

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other