BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINJECT/ADRENACLICK

    MDR report key: 22504785 · Received July 15, 2025

    Report

    Report Number
    3002919960-2025-00021
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    July 1, 2025
    Report Date
    July 29, 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 WOULD NOT COME OUT AND IT FALL APART [PRODUCT DELIVERY MECHANISM ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR INJECTION (NDC: (B)(4)) (LOT NO, EXPIRY DATE, S/N, AND STRENGTH WERE NOT REPORTED) VIA INTRAMUSCULAR ROUTE FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE PATIENT¿S CO-WORKER TRIED TO ADMINISTER THE MEDICATION TO THE PATIENT, AND THE MEDICATION WOULD NOT COME OUT AND IT FELL APART. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT AS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Description of Event or Problem · 0

    MEDICATION WOULD NOT COME OUT AND IT FALL APART [PRODUCT DELIVERY MECHANISM ISSUE]. THE BOTTOM PART OF THE MEDICATION FALLS APART (BROKEN APART) [DEVICE BREAKAGE]. TIREDNESS IN THE CHEST [CHEST DISCOMFORT]. COULD NOT BREATHE/ BREATHING ISSUE [DYSPNOEA]. CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON 07-JUL-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR INJECTION (NDC: 0115-1694-30) (LOT NO, EXPIRY DATE, S/N, AND STRENGTH WERE NOT REPORTED) VIA INTRAMUSCULAR ROUTE FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE PATIENT¿S CO-WORKER TRIED TO ADMINISTER THE MEDICATION TO THE PATIENT, AND THE MEDICATION WOULD NOT COME OUT AND IT FELL APART. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT AS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. SIGNIFICANT FOLLOW UP (#1) INFORMATION WAS RECEIVED ON 08-JUL-2025. FOLLOW UP INFORMATION WAS RECEIVED FROM THE PATIENT VIA A TELEPHONIC CALL. NEW INFORMATION INCLUDED ADDITIONAL EVENTS DEVICE BREAKAGE, CHEST DISCOMFORT, AND DYSPNOEA; SUSPECT DRUG INFORMATION (STRENGTH, LOT NO., INDICATION, AND START DATE), AND CURRENT CONDITIONS WERE ADDED, AND NARRATIVE HAS BEEN UPDATED. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG INJECTION (NDC: 0115-1694-30, LOT NO: G240107X) VIA INTRAMUSCULAR ROUTE FOR ANAPHYLACTIC REACTION DUE TO PEANUT ALLERGIES. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. THE PATIENT HAD PEANUT ALLERGIES. CO-SUSPECT, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. ON AN UNKNOWN DATE OF 2025, THE PATIENT RECEIVED A SEALED MEDICATION FORM PHARMACY AND KEPT IT IN CARRYING CASE STORED IN HER BAG. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT¿S CO-WORKER TRIED TO INJECT THE EPINEPHRINE TO PATIENT DURING AN ANAPHYLACTIC REACTION (PATIENT COULD NOT BREATHE) DUE TO PEANUT ALLERGIES AND NOTICED THAT THE MEDICATION WAS NOT COMING OUT AND THE BOTTOM PART OF THE MEDICATION FALLS APART (BROKEN APART). THE PATIENT RUSHED TO ER FOR 04 AND HALF HOUR TO GET ANOTHER DOSE OF EPINEPHRINE AS MEDICATION WAS NOT COMING OUT AND WAS DISCHARGED ON THE SAME DAY. THE PATIENT WAS NOT AWARE IF THE NOSE CAP WAS PLACED ON OUTER THIGH AND IF SHE HEARD THE CLICK SOUND WHEN INJECTING AS THE PATIENT COULD NOT BREATHE DURING THE TIME OF ADMINISTRATION OF EPINEPHRINE. IT WAS FURTHER REPORTED THAT, THE PATIENT WAS STILL RECOVERING AND STILL HAVING BREATHING ISSUE AND TIREDNESS IN THE CHEST. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO PRODUCT DELIVERY MECHANISM ISSUE, DEVICE BREAKAGE, CHEST DISCOMFORT, AND DYSPNOEA WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND DEVICE BREAKAGE WERE UNKNOWN. THE OUTCOME OF EVENTS CHEST DISCOMFORT AND DYSPNOEA WAS RESOLVING. THE REPORTER DID NOT ASSESS THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE, DEVICE BREAKAGE, CHEST DISCOMFORT, AND DYSPNOEA WITH RESPECT TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Description of Event or Problem · 0

    MEDICATION WOULD NOT COME OUT AND IT FALL APART [PRODUCT DELIVERY MECHANISM ISSUE], THE BOTTOM PART OF THE MEDICATION FALLS APART (BROKEN APART) [DEVICE BREAKAGE], LOT HAD EXPIRED ON 30-JUN-2025, PRIOR TO THE REPORTED ISSUE. [EXPIRED PRODUCT ADMINISTERED]. TIREDNESS IN THE CHEST [CHEST DISCOMFORT], COULD NOT BREATHE/ BREATHING ISSUE [DYSPNOEA]. CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON 07-JUL-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR INJECTION (NDC: 0115-1694-30) (LOT NO, EXPIRY DATE, S/N, AND STRENGTH WERE NOT REPORTED) VIA INTRAMUSCULAR ROUTE FOR AN UNKNOWN INDICATION. CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, THE PATIENT¿S CO-WORKER TRIED TO ADMINISTER THE MEDICATION TO THE PATIENT, AND THE MEDICATION WOULD NOT COME OUT AND IT FELL APART. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND NO ADVERSE EVENT AS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. SIGNIFICANT FOLLOW UP (#1) INFORMATION WAS RECEIVED ON 08-JUL-2025. FOLLOW UP INFORMATION WAS RECEIVED FROM THE PATIENT VIA A TELEPHONIC CALL. NEW INFORMATION INCLUDED ADDITIONAL EVENTS DEVICE BREAKAGE, CHEST DISCOMFORT, AND DYSPNOEA; SUSPECT DRUG INFORMATION (STRENGTH, LOT NO., INDICATION, AND START DATE), AND CURRENT CONDITIONS WERE ADDED, AND NARRATIVE HAS BEEN UPDATED. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG INJECTION (NDC: 0115-1694-30, LOT NO: G240107X) VIA INTRAMUSCULAR ROUTE FOR ANAPHYLACTIC REACTION DUE TO PEANUT ALLERGIES. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC REACTION. THE PATIENT HAD PEANUT ALLERGIES. CO-SUSPECT, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. ON AN UNKNOWN DATE OF 2025, THE PATIENT RECEIVED A SEALED MEDICATION FORM PHARMACY AND KEPT IT IN CARRYING CASE STORED IN HER BAG. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT¿S CO-WORKER TRIED TO INJECT THE EPINEPHRINE TO PATIENT DURING AN ANAPHYLACTIC REACTION (PATIENT COULD NOT BREATHE) DUE TO PEANUT ALLERGIES AND NOTICED THAT THE MEDICATION WAS NOT COMING OUT AND THE BOTTOM PART OF THE MEDICATION FALLS APART (BROKEN APART). THE PATIENT RUSHED TO ER FOR 04 AND HALF HOUR TO GET ANOTHER DOSE OF EPINEPHRINE AS MEDICATION WAS NOT COMING OUT AND WAS DISCHARGED ON THE SAME DAY. THE PATIENT WAS NOT AWARE IF THE NOSE CAP WAS PLACED ON OUTER THIGH AND IF SHE HEARD THE CLICK SOUND WHEN INJECTING AS THE PATIENT COULD NOT BREATHE DURING THE TIME OF ADMINISTRATION OF EPINEPHRINE. IT WAS FURTHER REPORTED THAT, THE PATIENT WAS STILL RECOVERING AND STILL HAVING BREATHING ISSUE AND TIREDNESS IN THE CHEST. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO PRODUCT DELIVERY MECHANISM ISSUE, DEVICE BREAKAGE, CHEST DISCOMFORT, AND DYSPNOEA WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE AND DEVICE BREAKAGE WERE UNKNOWN. THE OUTCOME OF EVENTS CHEST DISCOMFORT AND DYSPNOEA WAS RESOLVING. THE REPORTER DID NOT ASSESS THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE, DEVICE BREAKAGE, CHEST DISCOMFORT, AND DYSPNOEA WITH RESPECT TO EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. FOLLOW-UP (#2) INFORMATION RECEIVED ON 16-JUL-2025. SIGNIFICANT INFORMATION RECEIVED FROM PATIENT VIA A MAIL. ADDITIONAL INFORMATION INCLUDED PRODUCT EXPIRATION DATE AND NEW EVENT EXPIRED PRODUCT ADMINISTERED WAS ADDED TO THE CASE AND NARRATIVE WAS UPDATED. ON AN UNKNOWN DATE IN (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG INJECTION (NDC: 0115-1694-30, LOT NO: G240107X, EXP. DATE: 30-JUN-2025) VIA INTRAMUSCULAR ROUTE FOR ANAPHYLACTIC REACTION DUE TO PEANUT ALLERGIES. IN (B)(6) 2025, A PRODUCT-RELATED CONCERN WAS REPORTED INVOLVING LOT G240107X. UPON REVIEW, IT WAS CONFIRMED THAT THE LOT HAD EXPIRED ON 30-JUN-2025, PRIOR TO THE EXPERIENCING EVENTS. THE PRODUCT WAS USED BEYOND ITS APPROVED SHELF LIFE AND EXPIRATION DATE. INVESTIGATION IS NOT WARRANTED AS THE PRODUCT WAS EXPIRED AT THE TIME OF USE. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO PRODUCT DELIVERY MECHANISM ISSUE, DEVICE BREAKAGE, CHEST DISCOMFORT, DYSPNOEA AND EXPIRED PRODUCT ADMINISTERED WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE, DEVICE BREAKAGE, AND EXPIRED PRODUCT ADMINISTERED WERE UNKNOWN. THE OUTCOME OF EVENTS CHEST DISCOMFORT AND DYSPNOEA WAS RESOLVING. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS PRODUCT DELIVERY MECHANISM ISSUE, DEVICE BREAKAGE, EXPIRED PRODUCT ADMINISTERED, CHEST DISCOMFORT, AND DYSPNOEA WITH EPINEPHRINE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572228 TWINJECT/ADRENACLICK TYPE 2 PQX PHILLIPS-MEDISIZE LLC G240107X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other