BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADRENACLICK

    MDR report key: 23193007 · Received October 1, 2025

    Report

    Report Number
    3002919960-2025-00037
    Event Type
    Malfunction
    Date Received
    October 1, 2025
    Date of Event
    January 1, 2025
    Report Date
    October 10, 2025
    Manufacturer
    PHILLIPS-MEDISIZE LLC
    Product Code
    PQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    MEDICATION WAS BROKEN AND SPILLED/ 01 EPI PEN WAS BROKEN AND SPILLED WHILE USING [DEVICE BREAKAGE] MEDICATION WAS BROKEN AND SPILLED/ 01 EPI PEN WAS BROKEN AND SPILLED WHILE USING [DEVICE LEAKAGE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT IN A 25-YEAR-OLD FEMALE PATIENT (RACE WAS NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A PHARMACIST VIA A TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE AUTO-INJECTOR). ADDITIONAL SIGNIFICANT FOLLOW-UP (#01) INFORMATION RECEIVED FROM THE PATIENT¿S FATHER VIA A TELEPHONIC CALL. FOLLOW-UP INFORMATION INCLUDE: ADDED ADDITIONAL REPORTER, ADDED PATIENT DEMOGRAPHICS, UPDATED EVENT VERBATIM FOR EVENTS DEVICE BREAKAGE AND DEVICE LEAKAGE AND NARRATIVE WAS UPDATED. ON AN UNKNOWN DATE IN 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG, (NDC: (B)(4), LOT NO: G250406X, EXPIRY DATE: 31-DEC-2026) (SERIAL NUMBER, DOSE AND FREQUENCY WERE NOT REPORTED) VIA SUBCUTANEOUS ROUTE FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDE ANAPHYLACTIC REACTION. THE PATIENT HAD NO CONCOMITANT DATA, ALLERGY DATA, TEST DATA AND PAST MEDICAL AND SURGICAL HISTORY. CO-SUSPECT MEDICATION, SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED THE MEDICATION FROM PHARMACY, AND ON AN UNKNOWN DATE IN 2025, WHEN IT WAS ABOUT TO BE ADMINISTERED TO THE PATIENT, THE NURSE NOTICED THAT THE 01 EPI PEN MEDICATION WAS BROKEN AND SPILLED WHILE USING. IT WAS UNKNOWN IF THE PATIENT RECEIVED THE SECOND MEDICATION. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY OF EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 04-OCT-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THE COMPREHENSIVE INVESTIGATION INTO COMPLAINT (B)(4) CONCERNING AN ALLEGED DEFECTIVE EPINEPHRINE INJECTION USP AUTO-INJECTOR HAS DEMONSTRATED THAT ALL MANUFACTURING PROCESSES, QUALITY CONTROLS, AND RELEASE TESTING FOR THE IMPLICATED LOT (G250406X) WERE CONDUCTED IN FULL COMPLIANCE WITH ESTABLISHED STANDARDS AND SPECIFICATIONS. FOR LOT G250406X, IN-PROCESS TESTING WAS PERFORMED ON 200 UNITS, AND FINAL RELEASE TESTING WAS COMPLETED ON 50 COMPOSITE UNITS. IN ALL CASES, DEVICES MET OR EXCEEDED ALL FUNCTIONAL, DIMENSIONAL, AND PERFORMANCE CRITERIA, WITH NO ANOMALIES OR DEVIATIONS IDENTIFIED THAT COULD EXPLAIN THE REPORTED COMPLAINT. EVALUATION OF RETAINED SAMPLES CONFIRMED THAT THE DEVICES OPERATED AS INTENDED, WITH NO MECHANICAL OR FUNCTIONAL DEFECTS OBSERVED. HISTORICAL COMPLAINT DATA AND TREND ANALYSES FURTHER SUPPORT THE ROBUSTNESS AND CONTROL OF THE PRODUCT AND MANUFACTURING PROCESSES, AS EVIDENCED BY A LOW FREQUENCY OF SIMILAR COMPLAINTS. ALTHOUGH THE PRECISE ROOT CAUSE OF THE REPORTED THERAPEUTIC FAILURE REMAINS UNDETERMINED DUE TO LIMITED INFORMATION FROM THE COMPLAINANT, THE INVESTIGATION SUGGESTS THAT USER OR OPERATOR FACTORS MAY HAVE CONTRIBUTED. OVERALL, THE INVESTIGATION AFFIRMS THE QUALITY, RELIABILITY, AND SAFETY OF THE PRODUCT AND MANUFACTURING SYSTEMS. NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. CONTINUOUS QUALITY ASSURANCE AND MONITORING WILL CONTINUE TO ENSURE PRODUCT EFFICACY AND PATIENT SAFETY. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY OF EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS CASE HAS DEVICE COMPLAINT ASSOCIATED. THE INVESTIGATION REPORT WAS ASSESSED NOT TO HAVE THE POSSIBILITY OF CAUSING ANY FUTURE HARM TO OTHER USERS OF THE PRODUCT.

    Description of Event or Problem · 0

    MEDICATION WAS BROKEN AND SPILLED/ 01 EPI PEN WAS BROKEN AND SPILLED WHILE USING [DEVICE BREAKAGE], MEDICATION WAS BROKEN AND SPILLED/ 01 EPI PEN WAS BROKEN AND SPILLED WHILE USING [DEVICE LEAKAGE] , NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT IN A 25-YEAR-OLD FEMALE PATIENT (RACE WAS NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 19-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A PHARMACIST VIA A TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE AUTO-INJECTOR). ADDITIONAL SIGNIFICANT FOLLOW-UP (#01) INFORMATION RECEIVED FROM THE PATIENT¿S FATHER VIA A TELEPHONIC CALL. FOLLOW-UP INFORMATION INCLUDE: ADDED ADDITIONAL REPORTER, ADDED PATIENT DEMOGRAPHICS, UPDATED EVENT VERBATIM FOR EVENTS DEVICE BREAKAGE AND DEVICE LEAKAGE AND NARRATIVE WAS UPDATED. ON AN UNKNOWN DATE IN 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG, (NDC: 0115-1694-49, LOT NO: G250406X, EXPIRY DATE: 31-DEC-2026) (SERIAL NUMBER, DOSE AND FREQUENCY WERE NOT REPORTED) VIA SUBCUTANEOUS ROUTE FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITIONS INCLUDE ANAPHYLACTIC REACTION. THE PATIENT HAD NO CONCOMITANT DATA, ALLERGY DATA, TEST DATA AND PAST MEDICAL AND SURGICAL HISTORY. CO-SUSPECT MEDICATION, SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED THE MEDICATION FROM PHARMACY, AND ON AN UNKNOWN DATE IN 2025, WHEN IT WAS ABOUT TO BE ADMINISTERED TO THE PATIENT, THE NURSE NOTICED THAT THE 01 EPI PEN MEDICATION WAS BROKEN AND SPILLED WHILE USING. IT WAS UNKNOWN IF THE PATIENT RECEIVED THE SECOND MEDICATION. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE CAUSALITY OF EVENTS DEVICE BREAKAGE, DEVICE LEAKAGE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1795610 ADRENACLICK TYPE 2 PQX PHILLIPS-MEDISIZE LLC G250406X

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Female Other