BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINALHEALTH

    MDR report key: 19102591 · Received April 13, 2024

    Report

    Report Number
    3005670221-2024-00062
    Event Type
    Malfunction
    Date Received
    April 13, 2024
    Report Date
    April 13, 2024
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD.
    Product Code
    PNR
    UDI-DI
    06971564466257
    PMA / PMN Number
    K190502
    Removal / Correction Number
    Z-0850-2024
    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 NO PUMP COMPATBILITY ISSUES WITH THIS PRODUCT WERE RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0850-2024. 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 THEY HAVE IDENTIFIED THAT THE CARDINAL HEALTH MONOJECT 60ML ENTERAL SYRINGES (REF (B)(4); LOT 230501) ARE NOT IDENTIFIED AS MONOJECT SYRINGES IN THEIR FEEDING PUMPS AND THEREFORE CANNOT DELIVER FEEDS TO BABIES. THIS IS CURRENTLY THE ONLY LOT NUMBER AVAILABLE TO THEM TO TEST, BUT 100% OF THOSE TESTED HAVE FAILED USING MULTIPLE PUMPS AND PUMP SETTINGS. THEY HAVE NOT EXPERIENCED ANY ISSUES WITH THE MONOJECT SYRINGES PACKAGED AS COVIDIEN MONOJECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779120 CARDINALHEALTH ENFIT ENTERAL SYRINGE PNR JIANGSU CAINA MEDICAL CO., LTD. 230501 06971564466257

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other