BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINALHEALTH

    MDR report key: 19102792 · Received April 13, 2024

    Report

    Report Number
    3005670221-2024-00064
    Event Type
    Malfunction
    Date Received
    April 13, 2024
    Report Date
    April 13, 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

    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 SUBMISSION 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 TWO PUMP COMPATABILITY ISSUES WITH THIS PRODUCT WERE RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0849-2024. THE CORRECTIVE 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 IN THE AM THEY IDENTIFIED A MAJOR PROBLEM WITH THE CARDINAL ENFIT 35 ML SYRING, IT WILL NOT WORK IN THEIR MEDELA FEEDING PUMP. THEY HAVE THE PUMP PROGRAMMED FOR THE ENFIT BRAND AND BIOMED HAS BEEN TO THE UNIT TO EVALUATE AND ARE UNABLE TO CHANGE THE PUMP SETTINGS. THEY DO NOT HAVE ANY OTHER FEEDING PUMPS AVAILABLE TO THE NICU. WHAT WAS IDENTIFIED IS THAT THE NICU HAS BEEN USING THE ENFIT SYRINGES (PURPLE ONES) PER THE CHANGE HOWEVER THEY HAVE BEEN RECEIVING THE COVIDIEN BRAND NOT THE CARDINAL BRAND. TODAY THEY RECEIVED THE CARDINAL BRAND AND THEY DO NOT WORK. THEY LOOK SIMILAR BUT ARE A DIFFERENT DIAMETER. THEY DO NOT WORK IN THE PUMPS. THE WORK AROUND FOR TODAY IS TO USE THE COVIDIEN 60ML SYRINGES. HOWEVER THEY HAVE CONCERNS THAT THEY MAY ALSO BE SWITCHED TO THE CARDINAL BRAND LEAVING NO WORK AROUND TO FEED THE NICU INFANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779149 CARDINALHEALTH ENFIT ENTERAL SYRINGE PNR JIANGSU CAINA MEDICAL CO., LTD. 230501 06971564466240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other