BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BRASSELER TRITON ALL IN ONE IRRIGATION SOLUTION

    MDR report key: 21921097 · Received April 28, 2025

    Report

    Report Number
    3000209941-2025-44257
    Event Type
    Injury
    Date Received
    April 28, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 24, 2025
    Manufacturer
    INTER-MED, INC.
    Product Code
    KJJ
    UDI-DI
    00887919884699
    PMA / PMN Number
    K193357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF THE DEFECT, MALFUNCTION OR ERROR IN USE OF THE DEVICE: THE SYRINGE DETACHED FROM THE TRITON BOTTLE DURING THE FILLING PROCESS. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, THE DEVICE WAS NOT RETURNED BY THE CUSTOMER/DISTRIBUTOR, PREVENTING A DIRECT EVALUATION. BASED ON THE AVAILABLE INFORMATION, THE INCIDENT APPEARS MORE LIKELY TO BE DUE TO THE SYRINGE NOT BEING FULLY ENGAGED WITH THE DEVICE CAP, RATHER THAN A DEVICE MALFUNCTION. ROOT CAUSE OF THE PROBLEM: A REQUEST FOR ADDITIONAL INFORMATION WAS SENT TO THE DISTRIBUTOR ON 3/31/2025 FOR RELAY TO THE IMPACTED CUSTOMER, WITH FOLLOW-UP ATTEMPTS MADE ON 4/9/2025 AND 4/15/2025. NO RESPONSE WAS RECEIVED, AND NO PRODUCT WAS RETURNED TO INTER-MED, INC. FOR EVALUATION. AS A RESULT, LIMITED INFORMATION WAS AVAILABLE TO DETERMINE THE ROOT CAUSE. HOWEVER, BASED ON THE DETAILS PROVIDED, IT IS SUSPECTED THAT THE SYRINGE WAS NOT FULLY ENGAGED WITH THE CAP, AS INSTRUCTED IN THE DEVICE IFU. FURTHERMORE, INCOMING INSPECTION RECORDS FOR A LOT OF CAPS (PART NUMBER 2862 LOT NUMBER 24081) USED IN TRITON KIT LOT NUMBER 2024-3032 WERE REVIEWED, AND NO ANOMALIES WERE IDENTIFIED. CRITICAL DEFECT #4 ON RIP-260, 2862 2875 TRITON CAP ASSEMBLY RECEIVING INSPECTION PROCEDURE, CHECKS SPECIFICALLY FOR ENGAGEMENT OF A SYRINGE WITH THE TRITON CAP. 0 DEFECTS WERE IDENTIFIED FOR CAP LOT NUMBER 24081. COMBINED WITH NO OTHER COMPLAINTS/INCIDENTS WITH TRITON KITS THAT CONSUMED THIS LOT OF CAPS, THIS SUPPORTS THAT THERE ARE NO SYSTEMIC ISSUES WITH THIS LOT OF CAPS. FACTORS THAT MAY CONTRIBUTE TO PRODUCT RISK (I.E. DEVICE DESIGN, MANUFACTURING PROBLEMS OR USER ERROR): INHERENT CHEMICAL RISK ASSOCIATED WITH SODIUM HYPOCHLORITE IT IS SUSPECTED THAT THE USER DID NOT WEAR PROTECTIVE EYEWEAR AS DIRECTED IN THE IFU IT IS SUSPECTED THAT THE SYRINGE MAY NOT HAVE BEEN FULLY ENGAGED WITH THE TRITON BOTTLE CAP. DESIGN FACTORS THAT MIGHT MITIGATE RISK: LUER LOCK CONNECTION: THE TRITON BOTTLE CAP USES A STANDARD LUER SCREW-IN CONNECTION TO SECURELY ATTACH THE SYRINGE. WHEN FULLY ENGAGED, THIS DESIGN PROVIDES A STABLE AND RELIABLE CONNECTION THAT SHOULD PREVENT ACCIDENTAL DISCONNECTION DURING USE. PROPER ENGAGEMENT IS CRITICAL TO MAINTAINING THIS SECURE INTERFACE. INSTRUCTIONS FOR USE (IFU) - PROTECTIVE EYEWEAR: THE IFU CLEARLY INSTRUCTS USERS TO WEAR APPROPRIATE PROTECTIVE EYEWEAR WHEN HANDLING SODIUM HYPOCHLORITE. THIS SERVES AS A CRITICAL SAFEGUARD AGAINST CHEMICAL EXPOSURE, INCLUDING ACCIDENTAL SPLASHES OR SPRAYS, AS OCCURRED IN THIS INCIDENT.

    Description of Event or Problem · 0

    ON 3/31/2025, INTER-MED, INC. WAS MADE AWARE OF AN INCIDENT THAT OCCURRED ON (B)(6) 2025 IN WHICH THE SYRINGE DETACHED FROM THE TRITON BOTTLE WHILE THE SYRINGE WAS BEING FILLED, RESULTING IN TRITON SOLUTION SPRAYING INTO THE EMPLOYEE'S RIGHT EYE AND EAR, AS WELL AS ONTO THE EMPLOYEE'S FOREHEAD, CHEEK, NECK, AND CHEST. EMERGENCY EYEWASH WAS PERFORMED, AND THE EMPLOYEE WENT TO THE ER FOR ADDITIONAL TREATMENT AND TESTING, INCLUDING EYE WASHES AND PH TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224005 BRASSELER TRITON ALL IN ONE IRRIGATION SOLUTION CLEANSER, ROOT CANAL KJJ INTER-MED, INC. 2024-3032 00887919884699

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention