BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19095668 · Received April 12, 2024

    Report

    Report Number
    3005670221-2024-00017
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Report Date
    April 12, 2024
    Manufacturer
    JIANGSU CAINA MEDICAL CO., LTD.
    Product Code
    FMF
    UDI-DI
    10192253034691
    PMA / PMN Number
    K113091
    Removal / Correction Number
    Z-0856-2024
    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 TWO PUMP COMPATBILITY ISSUES WITH THIS PRODUCT WERE RECEIVED BEFORE. A RECALL WAS CONDUCTED BY DISTRIBUTOR CARDINAL HEALTH 200 LLC WITH RECALL NUMBER Z-0856-2024. THE CORRETIVE ACTION PUTTING THE CAUTION "FOR MANUAL USE OR NOT FOR PUMP USE" ON ALL SYRINGES' LABELING OF K113091 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 CHAT IN NUCLEAR RADIOLOGY STATED THAT THE INJECTION PUMPS WERE NOT RECORDING THE CORRECT VOLUME. HE WOULD SETUP A SYRINGE WITH A 30 ML DOSE, BUT THE BD ALARIS SYRINGE PUMP WOULD SHOW A 32.5 VOLUME. HE WAS USING THE SAME SETUP AS HE ALWAYS DID: MONOJECT 35 ML. HE ALSO MENTIONED THAT HE GOT NEW SYRINGES, AND THAT THE NEW SYRINGES WERE EASIER TO OPERATE. AFTER DOING TEST WITH THE NEW SYRINGE, THE INITIAL REPORTER WAS ABLE TO CONFIRM ACROSS EVERY TEST POINT THAT THE NEW MONOJECT SYRINGES WERE CONSTANTLY ABOUT 2.4 TO 2.5 ML OFF (EXTRA)- THEY WOULD SETUP A 20 ML INJECTION, BUT THE BD ALARIS SHOWED 22.4 ML. THIS VARIANCE WAS CONSISTENT FOR 10,20, 30 AND 35 ML. SEE PIC FOR THE 20 ML SYRINGE SETUP- ON THE SCREEN IT SHOWS'AVAILABLE 22.4 ML' THEY RECALIBRATED THE SYRINGE PUMP, SAME RESULTS. THEY TRIED THE SYRINGE ON DIFFERENT SYRINGE PUMPS, SAME RESULT, SO THEY CAN RULE OUT A BAD SYRINGE PUMP. FOUND AN OLD SYRINGE. TESTED IT. IT WAS ACCURATE TO WITHIN A 0.2ML, WHICH IS JUST A DROP. SO THEY EXAMINED BOTH SYRINGES AND FOUND THAT THE NEW MONOJECT 35 ML SYRINGES HAVE A LONGER BARREL. SINCE THE BD ALARIS CALIBRATION IS DETERMINED FROM THE AMOUNT OF THE BARREL ABOVE THE ZERO LINE (THE END PART OF THE SYRINGE BODY THAT CLAMPS INTO THE PUMP) THIS IS CAUSING THE BD ALARIS TO INACCURATELY ESTIMATE THE TOTAL VOLUME IN THE SYRINGE. THEY ARE NOT SURE IF IT WILL ACTUALLY CAUSE THE REPORTED TOTAL VOLUME INFUSED TO BE DIFFERENT OR NOT. THEY WOULD HAVE TO RUN ADDITIONAL TEST. THEY DO NOT KNOW HOW THE BD SYRINGE PUMP CALCULATES THE FINAL VOLUME ONCE THE PUMP HAS PRESSED DOWN ON THE SYRINGE TO THE STOP POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838051 CARDINAL HEALTH SYRINGE FMF JIANGSU CAINA MEDICAL CO., LTD. 221201 10192253034691

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other