BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19095080 · Received April 12, 2024

    Report

    Report Number
    3005670221-2024-00005
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Report Date
    April 12, 2024
    Manufacturer
    JIANGSU CAINA MEDLICAL CO., LTD.
    Product Code
    FMF
    UDI-DI
    10192253034677
    PMA / PMN Number
    K113091
    Removal / Correction Number
    Z-0150-2024
    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-0150-2024. THE CORRETIVE ACTION PUTTING THE CAUTION "FOR MANUAL USE OR NOT FOR PUMP USE" ON ALL ENTERAL SYRINGES' LABELING OF (B)(6) 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 THE MONOJECT SYRINGES THAT ARE USED FOR THE ANESTHESIA SYRINGE PUMPS, HAVE CHANGED AND IT IS AFFECTING THE ABILITY OF THE SYRINGE PUMP TO RECOGNIZE IT. IN THE PICTURES ATTACHED, THE COVIDIEN MONOJECT IS ON THE LEFT AND THE CARDINAL HEALTH MONOJECT ON THE RIGHT. THE CARDINAL HEALTH MONOJECT NO LONGER WORKS WITH THE PUMP. ONCE THE PACKAGE IS OPEN THE STAFF CANNOT TELL THEM APART BECAUSE COVIDIEN OR CARDINAL HEALTH IS NOT WRITTEN ON THE SYRINGE TO IDENTIFY IT. THE CARDINAL HEALTH VERSION HAS A WIDER FLANGE AT THE BASE. THE NEW VERSION OF THE SYRINGE DOES NOT ALLOW FOR PROPER CALIBRATION OF THE SYRINGE PUMP AND MAY LEAD TO INACCURATE DOSING OF ANESTHETIC DRUGS. BD AND MONOJECT SYRINGES ARE THE ONLY ONES APPROVED FOR THE OR DUE TO COMPATIBILITY WITH THE ANESTHESIA SYRINGE PUMPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779624 CARDINAL HEALTH SYRINGE FMF JIANGSU CAINA MEDLICAL CO., LTD. 221202 10192253034677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other