BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE,10ML,ANGIO,W/RA,-,OEM

    MDR report key: 23610295 · Received November 20, 2025

    Report

    Report Number
    3015910259-2025-00109
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Report Date
    December 5, 2025
    Manufacturer
    MEDLINE INDUSTRIES, LP - NAMIC
    Product Code
    DXT
    UDI-DI
    10193489066838
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DURING PRIMING, THE CONTROL SYRINGE WAS CONNECTED TO THE MANIFOLD AND FILLED WITH CONTRAST. WHEN THE STOPCOCK WAS OPENED, THE SYRINGE DETACHED FROM THE MANIFOLD UNDER PRESSURE, ALLOWING AIR INTO THE LINE. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY IF IT WERE TO OCCUR. IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    UPDATE TO H6. AFTER FURTHER INVESTIGATION, IT HAS BEEN DETERMINED THAT THE INVESTIGATION INVOLVED AN ANALYSIS OF PRODUCTION RECORDS, TREND ANALYSIS, AND THAT THE DEVICE WAS NOT RETURNED. THE INVESTIGATION HAD NO FINDINGS AND CONCLUDED THAT A CAUSE COULD NOT BE ESTABLISHED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING FILED TO CLARIFY THE INFORMATION RECEIVED BY MEDLINE INDUSTRIES, LP RELATED TO THIS EVENT. IT WAS ORIGINALLY REPORTED ON (B)(6) 2025 THAT A SYRINGE DETACHED FROM A MANIFOLD DURING PRIMING AND THAT AIR WENT INTO THE LINE. AT THAT TIME, IT WAS INDICATED THAT THE SYRINGE WAS REPLACED WITH A NEW COMPONENT AND THAT THE ISSUE WAS "RESOLVED." NO PRODUCT INFORMATION FOR THE REPLACEMENT COMPONENT WAS PROVIDED, AND IT IS UNKNOWN IF THE NEW SYRINGE WAS A MEDLINE INDUSTRIES, LP PRODUCT. ON (B)(6) 2025 IT WAS REPORTED TO MEDLINE INDUSTRIES, LP THAT "AIR WAS INJECTED INTO THE PATIENT'S CORONARY ARTERY" AND THE PATIENT WAS PROVIDED HIGH FLOW OXYGEN AS A "PREVENTATIVE MEASURE". ADDITIONAL INFORMATION WAS PROVIDED TO MEDLINE INDUSTRIES, LP ON 04-DEC-2025 PROVIDING FURTHER CLARIFICATION. ACCORDING TO THE FACILITY "WHEN THE PROCEDURE BEGAN, THE LINE WAS PRIMED AND ATTACHED TO THE PATIENT, THE FIRST INJECTION OF FLUID WAS WITHOUT CHALLENGES". PER THE FACILITY "THE SYRINGE WAS FILLED FOR THE SECOND TIME BY ADJUSTING THE STOPCOCK AND PULLING SOLUTION INTO THE SYRINGE, WHEN THIS WAS INJECTED, IT WAS NOTED ON THE X-RAY THAT THE PATIENT HAD AIR INJECTED". PER THE FACILITY "THE SYRINGE HAD NOT BEEN DISCONNECTED FROM THE MANIFOLD TO BE REFILLED DURING THIS TIME". PER THE FACILITY "THE ENTIRE LINE WAS DISCARDED, AND A NEW HAND INJECTION PACK WAS OPENED, PRIMED, AND USED WITHOUT INCIDENT". ACCORDING TO THE FACILITY "THE THOUGHT WAS THAT THERE WAS NOT A GOOD SEAL ON THE MANIFOLD/SYRINGE AND AIR LEAKED INTO THE LINE WITHOUT NOTICE". IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY RELATED TO INJECTION OF AIR AND THE PATIENT WAS SUBSEQUENTLY DISCHARGED HOME. AT THIS TIME, WE ARE UNABLE TO CONFIRM THE REPORTED DEFECT, AS NO PHYSICAL SAMPLE OR DETAILED PHOTOGRAPHIC EVIDENCE WAS PROVIDED TO SUPPORT THE INVESTIGATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF THE REPORTING FACILITY IS ABLE OR WILLING TO PROVIDE ADDITIONAL RELEVANT INFORMATION, ANOTHER SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THIS SUPPLEMENTAL REPORT IS BEING FILED TO CLARIFY THE INFORMATION RECEIVED BY MEDLINE INDUSTRIES, LP RELATED TO THIS EVENT. IT WAS ORIGINALLY REPORTED ON 26-OCT-2025 THAT A SYRINGE DETACHED FROM A MANIFOLD DURING PRIMING AND THAT AIR WENT INTO THE LINE. AT THAT TIME, IT WAS INDICATED THAT THE SYRINGE WAS REPLACED WITH A NEW COMPONENT AND THAT THE ISSUE WAS "RESOLVED." NO PRODUCT INFORMATION FOR THE REPLACEMENT COMPONENT WAS PROVIDED AND IT IS UNKNOWN IF THE NEW SYRINGE WAS A MEDLINE INDUSTRIES, LP PRODUCT. ON 04-NOV-2025 IT WAS REPORTED TO MEDLINE INDUSTRIES, LP THAT AIR WAS INJECTED INTO THE PATIENT. ALTHOUGH A CONCERN FOR A POTENTIAL AIR EMBOLISM WAS REPORTED, THIS WAS NOT CONFIRMED AND NO ADVERSE HEALTH IMPACT WAS INDICATED. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO DETAIL THE EVENTS THAT OCCURRED BETWEEN THE ORIGINALLY REPORTED RESOLUTION OF THE ISSUE AND THE SUBSEQUENT 04-NOV-2025 NOTIFICATION THAT AIR WAS INJECTED INTO THE PATIENT. IT IS UNKNOWN WHETHER THE LINE WAS RE-PRIMED OR CLEARED/PURGED OF AIR AFTER THE ORIGINAL COMPONENT DETACHED. IT IS PROCEDURALLY EXPECTED TO CHECK LINES FOR AIR AND CLEAR/PURGE AIR AS NEEDED WHEN CONNECTING OR DISCONNECTING COMPONENTS OR IN THE EVENT THAT A COMPONENT DETACHES. BASED ON INFORMATION KNOWN TO DATE, THE REPORTED INJECTION OF AIR INTO THE PATIENT IS BELIEVED TO HAVE OCCURRED AFTER THE NEW SYRINGE COMPONENT WAS OBTAINED AND USED FOR THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. IF THE REPORTING FACILITY IS ABLE OR WILLING TO PROVIDE ADDITIONAL RELEVANT INFORMATION, ANOTHER SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    DURING PRIMING, THE CONTROL SYRINGE WAS CONNECTED TO THE MANIFOLD AND FILLED WITH CONTRAST. WHEN THE STOPCOCK WAS OPENED, THE SYRINGE DETACHED FROM THE MANIFOLD UNDER PRESSURE, ALLOWING AIR INTO THE LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262322 SYRINGE,10ML,ANGIO,W/RA,-,OEM DXT MEDLINE INDUSTRIES, LP - NAMIC 0000102515 10193489066838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other