BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADRENACLICK

    MDR report key: 23876313 · Received December 23, 2025

    Report

    Report Number
    3002919960-2025-00046
    Event Type
    Malfunction
    Date Received
    December 23, 2025
    Report Date
    January 10, 2026
    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 CAME OUT OF THE INJECTOR WHILE ABOUT TO INJECT [DEVICE LEAKAGE]. 2ND EPIPEN THE NEEDLE DROPPED OUT [NEEDLE ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT IN A 63-YEARS-OLD MALE PATIENT (RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 63 YEARS. ON 16-DEC-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT WIFE VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTO-INJECTOR. THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: 00115-1694-49, BATCH NO: G240907X, EXP DATE: 31-MAY-2026) VIA SUBCUTANEOUS ROUTE FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/DRINKING, HISTORICAL DRUG AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. ON 13-SEP-2025, THEY RECEIVED THE SEALED MEDICATION BOX FROM HER PHARMACY AND ON AN UNKNOWN DATE WHEN THE PATIENT WAS ABOUT TO INJECT THE MEDICATION CAME OUT OF THE INJECTOR WHILE ABOUT TO INJECT FIRST EPIPEN AND WHEN THE PATIENT WAS ABOUT TO INJECT THE SECOND EPIPEN THE NEEDLE DROPPED OUT. UPON ASKING THAT DID PATIENT RECEIVE THE DOSE, SHE DENIED PROVIDING AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Description of Event or Problem · 0

    MEDICATION CAME OUT OF THE INJECTOR WHILE ABOUT TO INJECT [DEVICE LEAKAGE] 2ND EPIPEN THE NEEDLE DROPPED OUT [NEEDLE ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT IN A 63-YEARS-OLD MALE PATIENT (RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 63 YEARS. ON 16-DEC-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT WIFE VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTO-INJECTOR. THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: 00115-1694-49, BATCH NO: G240907X, EXP DATE: 31-MAY-2026) VIA SUBCUTANEOUS ROUTE FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/DRINKING, HISTORICAL DRUG AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. ON 13-SEP-2025, THEY RECEIVED THE SEALED MEDICATION BOX FROM HER PHARMACY AND ON AN UNKNOWN DATE WHEN THE PATIENT WAS ABOUT TO INJECT THE MEDICATION CAME OUT OF THE INJECTOR WHILE ABOUT TO INJECT FIRST EPIPEN AND WHEN THE PATIENT WAS ABOUT TO INJECT THE SECOND EPIPEN THE NEEDLE DROPPED OUT. UPON ASKING THAT DID PATIENT RECEIVE THE DOSE, SHE DENIED PROVIDING AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE LEAKAGE, NEEDLE ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 05-JAN-2026. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. ON 18-DEC-2025, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G240907X (EXP MAY-2026). THE COMPLAINANT REPORTED THAT MEDICATION DISCHARGED FROM THE FIRST AUTO-INJECTOR PRIOR TO ADMINISTRATION AND THAT THE NEEDLE REPORTEDLY DISLODGED FROM THE SECOND AUTO-INJECTOR. TWO DEVICES WERE REPORTED AS AFFECTED, AND THE PATIENT DENIED RECEIVING A DOSE AND REQUESTED A REPLACEMENT. THE COMPLAINT WAS CLASSIFIED AS DEFECTIVE INJECTOR. A PFIZER INVESTIGATION WAS NOT WARRANTED, AS THE REPORTED ISSUE WAS RELATED TO ASSEMBLY AND PACKAGING ACTIVITIES PERFORMED BY THE CPO, PHILLIPS MEDISIZE -MENOMONIE. PHILLIPS CONDUCTED AN INVESTIGATION; HOWEVER, THE COMPLAINT SAMPLE WAS NOT RETURNED AND NO SUPPORTING PHOTOGRAPHS OR ADDITIONAL INFORMATION WERE PROVIDED, PREVENTING DIRECT EVALUATION. A REVIEW OF MANUFACTURING, INSPECTION, AND RELEASE RECORDS FOR LOT G240907X CONFIRMED ALL PROCESSES WERE COMPLETED SUCCESSFULLY WITH NO DEVIATIONS OR DISCREPANCIES. NO OTHER COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT WITHIN THE PAST 24 MONTHS. COMPLAINT TRENDING INDICATES AN OVERALL DEFECTIVE INJECTOR COMPLAINT RATE OF (B)(4) PERCENT (35 COMPLAINTS OUT OF (B)(4) RELEASED TWO-PACK DEVICES). A REVIEW OF THE PFMEA CONFIRMED APPLICABLE FAILURE MODES ARE ADDRESSED WITHIN THE CURRENT ASSEMBLY PROCESS, AND A REVIEW OF THE PI/PIL, WRAP LABEL, AND CARTON CONFIRMED ADEQUATE INSTRUCTIONS FOR PROPER DEVICE PREPARATION, ADMINISTRATION, AND DISPOSAL. THE REPORTED EVENT IS HIGH SEVERITY BUT VERY LOW OCCURRENCE (0.00078 PERCENT), WITH NO ADDITIONAL COMPLAINTS FOR LOT G240907X. MANUFACTURING AND INSPECTION REVIEWS IDENTIFIED NO DEVIATIONS, AND EXISTING CONTROLS, PFMEA COVERAGE, AND LABELING ARE ADEQUATE. NO SYSTEMIC MANUFACTURING OR DESIGN RISK WAS IDENTIFIED. RESIDUAL RISK IS ACCEPTABLE, AND NO CAPA IS REQUIRED. BASED ON THE LIMITED INTAKE INFORMATION AND ABSENCE OF THE RETURNED PRODUCT, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. THEREFORE, THE ROOT CAUSE FOR THIS COMPLAINT IS DETERMINED TO BE UNDETERMINED, WITH NO EVIDENCE LINKING THE REPORTED EVENT TO THE MANUFACTURING OR ASSEMBLY PROCESSES AT PHILLIPS. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE LEAKAGE, NEEDLE ISSUE, AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE LEAKAGE, NEEDLE ISSUE, AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE LEAKAGE, NEEDLE ISSUE, AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1918568 ADRENACLICK TYPE 2 PQX PHILLIPS-MEDISIZE LLC G240907X

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other