BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDINAL HEALTH

    MDR report key: 19095875 · Received April 12, 2024

    Report

    Report Number
    3005670221-2024-00018
    Event Type
    Malfunction
    Date Received
    April 12, 2024
    Report Date
    April 12, 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

    SAMPLE IS UNAVAILABLE FOR EVALUATION. 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 ISSUES WITH THIS PRODUCT WAS 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 ENTERAL SYRINGES' LABELING OF K190502 WILL BE TAKEN. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION FROM THE RECEIVED SAMPLES.

    Description of Event or Problem · 0

    AS ALWAYS BEEN THIS CODE WHETHER THE PACKAGING SAID COVIDIEN OR CARDINAL. ADDITIONAL INFORMATION PROVIDED BY (B)(6) ON 31OCT2023 STATED THAT SHE MANAGES THE SOFTWARE FOR THE PUMPS IN THE NICU (IN WHICH THE SYRINGES IN QUESTION ARE INCOMPATIBLE WITH). THEY USE THE MEDFUSION 4000 PUMPS (VERSION V1.6.1) MANAGED BY ICU MEDICAL (FORMERLY SMITHS MEDICAL). SHE REACHED OUT TO THE PUMP VENDOR TO INQUIRE ABOUT MORE INFORMATION. THE REP SHE SPOKE WITH INDICATED THAT THIS ENFIT SYRINGE ISSUE IS RELATED TO A SIMILAR PROBLEM WITH LUER-LOCK SYRINGES REPORTED OVER THE LAST COUPLE OF MONTHS. CURRENTLY, THEY STILL HAVE SUPPLY IN THE NICU OF THE MONOJECT ENFIT SYRINGES (REF (B)(4)), BUT IT'S THE OLD COVIDIEN PACKAGING, LOT 322648X. THE INCOMPATIBLE LOT NUMBER IS 230501 WITH THE CARDINAL HEALTH MONOJECT PACKAGING. THEY ARE ASKING WHETHER THAT ABOVE LOT NUMBER (230501) IS UNIQUE AND THE ONLY INCOMPATIBILITY ISSUE THEY WILL ENCOUNTER, OR HAVE THERE BEEN ISSUES REPORTED WITH THE CARDINAL HEALTH BRANDED MONOJECT ENFIT SYRINGES (SIMILAR TO THE LUER-LOCK SYRINGE ISSUES)? THEY HAVE SOME OTHER OPTIONS TO MANAGE THIS ISSUE WITH THE PUMPS, BUT WAS WONDERING IF THERE WAS ANY FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833076 CARDINAL HEALTH ORAL SYRINGE PNR JIANGSU CAINA MEDICAL CO., LTD. 230501 06971564466240

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other