BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAVEN FAST FLASH 22G 25MM

    MDR report key: 25241622 · Received May 21, 2026

    Report

    Report Number
    3006846316-2026-00003
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 1, 2026
    Report Date
    April 1, 2026
    Manufacturer
    DELTA MED SPA
    Product Code
    FOZ
    PMA / PMN Number
    K200373
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT REPORT RECEIVED FROM THE FDA THROUGH THE US AGENT MR. (B)(6), 0500770000-2025-8026, RECEIVED ON 22/04/2026, INVOLVING A CLOSED-SYSTEM SAFETY INTRAVENOUS CATHETER, DELTAVEN USA FF G22X25MM LOT: 11T15251 CODE 3825773 MANUFACTURED BY OUR COMPANY, CONCERNING THE CAP THAT DID NOT DETACH FROM THE CATHETER BODY DURING NEEDLE REMOVAL, CAUSING EXPOSURE OF THE NEEDLE TIP (ANNEX A). FOUR (4) STERILE RETAINED SAMPLES OF DELTAVEN USA FF G22X25MM FROM LOT: 11T15251 RETRIEVED FROM THE INTERNAL ARCHIVE IN ORDER TO CARRY OUT INVESTIGATIONS AIMED AT IDENTIFYING MANUFACTURING DEFECTS AND DETERMINING WHETHER ANY ISSUES AFFECTED THE SAFETY SYSTEM. I - TESTS CARRIED OUT ON THE FOUR (4) DELTAVEN USA FF G22X25MM LOT: 11T15251 UNITS TAKEN FROM THE INTERNAL ARCHIVE TO VERIFY COMPLIANCE OF THE SAFETY SYSTEM AGAINST ACCIDENTAL NEEDLE-STICK INJURIES (SEE PHOTOS IN ANNEX B). FOLLOWING RETRIEVAL FROM THE INTERNAL ARCHIVE OF DEVICES FROM THE SAME LOT INVOLVED IN THE INCIDENT, THE FOLLOWING VERIFICATION ACTIVITIES WERE IMMEDIATELY PERFORMED IN ORDER TO ESTABLISH THE CAUSES OF THE INCIDENT: 1 - VISUAL INSPECTION OF THE SAFETY DEVICE TO VERIFY ITS INTEGRITY, COMPLETENESS, AND PROPER ASSEMBLY OF THE COMPONENTS ENSURING CORRECT OPERATION. THE INSPECTION REPORT IS AVAILABLE IN ANNEX C AND INCLUDES THE OBTAINED RESULTS; 2 - INSPECTION OF THE NEEDLE OVALIZATION WHICH, THROUGH INTERFERENCE WITH THE DIAMETER OF THE HOLE IN THE SAFETY SPRING, ACTIVATES THE SAFETY DEVICE THAT COVERS THE NEEDLE TIP. THE INSPECTION REPORT IS AVAILABLE IN ANNEX D AND INCLUDES THE OBTAINED RESULTS; 3 - DYNAMOMETRIC TESTING OF THE ACTIVATION OF THE SAFETY DEVICE AND ITS DETACHMENT FROM THE BUTTERFLY OR CATHETER BODY, ALLOWING VERIFICATION THAT THE SAFETY DEVICE ACTIVATED CORRECTLY AT THE END OF NEEDLE EXTRACTION. THE INSPECTION REPORT IS AVAILABLE IN ANNEX E AND INCLUDES THE OBTAINED RESULTS; 4 - SAFETY DEVICE EFFICIENCY TEST CONSISTING OF VERIFYING THAT, EVEN AFTER REPEATED ATTEMPTS TO FORCE THE NEEDLE TIP OUT OF THE SAFETY DEVICE, THE DEVICE PREVENTS ITS EXPOSURE. THE INSPECTION REPORT IS AVAILABLE IN ANNEX F AND INCLUDES THE OBTAINED RESULTS; 5 - TENSILE TEST OF THE ASSEMBLED NEEDLE-SAFETY DEVICE, DEFINING THE SEPARATION FORCE OF THE NEEDLE WITH THE OVALIZED SECTION FROM THE STEEL CLAMP COVERING THE NEEDLE TIP. SEE ANNEX F. ALL RESULTS OBTAINED WITH REFERENCE TO POINTS 1, 2, 3, 4, AND 5 ABOVE, CONFIRM THE SUITABILITY OF THE MANUFACTURED DEVICES AND THE ABSENCE OF MANUFACTURING DEFECTS IN THE PRODUCT BELONGING TO LOT: 11T15251. FURTHERMORE, TO CONFIRM THE CORRECT ASSEMBLY OF THE SAFETY SYSTEM ENSURING ITS FULL FUNCTIONALITY, IT SHOULD ALSO BE SPECIFIED THAT: 1 - THE AUTOMATIC ASSEMBLY SYSTEM FOR THE SAFETY DEVICE COVERING THE NEEDLE TIP, AS WELL AS THE SYSTEM ASSEMBLING IT INSIDE THE VENOUS CATHETER ARE EQUIPPED WITH SENSORS THAT VERIFY THE PRESENCE OF THE STEEL SAFETY SPRING IN THE SAFETY DEVICE ON 100% OF ASSEMBLED UNITS. 2 - THE AUTOMATIC ASSEMBLY SYSTEM FOR THE VENOUS CATHETER IS EQUIPPED WITH A VERIFICATION SYSTEM FOR THE PRESENCE OF THE NEEDLE OVALIZATION REQUIRED TO ACTIVATE THE SAFETY DEVICE FOR NEEDLE TIP COVERAGE ON 100% OF ASSEMBLED UNITS. 3 - EVERY PRODUCTION DAY, THE EFFICIENCY OF THE SENSORS DETECTING THE PRESENCE OF THE STEEL SAFETY SPRING AND THE NEEDLE OVALIZATION IS VERIFIED AND RECORDED. 4 - FURTHERMORE, THE BLISTER INTENDED TO CONTAIN THE PACKAGED MEDICAL DEVICE FEATURES A CAVITY IN THE PLASTIC TRAY THAT DOES NOT ALLOW INSERTION OF THE DEVICE IF THE ACCIDENTAL NEEDLE-STICK PREVENTION SAFETY DEVICE IS NOT CORRECTLY POSITIONED. THIS PREVENTS THE POSSIBILITY OF FINDING SAFETY DEVICES IMPROPERLY INSERTED ONTO THE CATHETER BODY THAT WOULD FAIL TO ACTIVATE DURING USE. THE SAMPLE INVOLVED IS AVAILABLE AT THE HOSPITAL; HOWEVER, THE DISTRIBUTOR DID NOT PROVIDE US WITH SUPPORT FOR THE COLLECTION WITHIN THE REQUIRED TIMEFRAME SO THAT WE WERE NOT ABLE TO INVESTIGATE IT. CONCLUSIONS: BASED ON THE INSPECTIONS PERFORMED AND DOCUMENTED ON DEVICES FROM THE SAME LOT INVOLVED IN THE INCIDENT, RETRIEVED FROM THE INTERNAL ARCHIVE, NO MANUFACTURING DEFECTS WERE IDENTIFIED THAT COULD HAVE CAUSED THE INCIDENT. THESE TESTS EXCLUDE THE POSSIBILITY OF A SERIAL DEFECT. AS NO EVIDENCE OF A DEFINITE CAUSE IS CURRENTLY AVAILABLE AND NO MANUFACTURING DEFECT WAS FOUND DURING THE INSPECTIONS PERFORMED, NO CORRECTIVE ACTIONS CAN PRESENTLY BE INITIATED ON OUR PART AIMED AT PREVENTING RECURRENCE OF THE EVENT.

    Description of Event or Problem · 0

    DESCRIBE THE EVENT OR PROBLEM: WHEN PLACING A CATHETER, THE CAP DID NOT DIS-ATTACH FORM THE HUB DURING NEEDLE REMOVAL. THIS LEFT AN EXPOSED SHARP NEEDLE TIP. NEITHER THE PATIENT NOR THE RN WERE POKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523500 DELTAVEN FAST FLASH 22G 25MM I.V. CATHETRS WITH CLOSED SYSTEM FOZ DELTA MED SPA 3825773 11T15251

    Patients

    Seq Age Sex Outcome Treatment
    1