ADRENACLICK
Report
- Report Number
- 3002919960-2025-00041
- Event Type
- Malfunction
- Date Received
- November 6, 2025
- Date of Event
- October 23, 2025
- Report Date
- January 3, 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
NEEDLE DID NOT COME OUT AFTER INJECTED THE MEDICATION TO OUTER THIGH AND DIDN'T HEAR ANY CLICK SOUND [DEVICE FAILURE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE WERE 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 THE PATIENT VIA A VOICE MAIL AND A TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTO-INJECTOR. ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: 0115-1694-30, BATCH NO: G250804X, EXP DATE: 30-APR-2027) VIA INTRAMUSCULAR ROUTE FOR ALLERGIC REACTION AND RASH. CONCURRENT CONDITIONS INCLUDED ALLERGIC REACTION AND RASH. 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 (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION FROM PHARMACY AND ON THE SAME DATE, THE PATIENT USED HER FIRST EPIPEN DURING AN ALLERGIC REACTION IT WORKED FINE FOR HER. ON (B)(6) 2025, THE PATIENT EXPERIENCED RASH AND SHE USED HER SECOND EPIPEN AND OBSERVED THAT THE NEEDLE DID NOT COME OUT AFTER SHE INJECTED THE MEDICATION TO OUTER THIGH AND STATED THAT SHE DIDN'T HEAR ANY CLICK SOUND. PATIENT DENIED PROVIDING COMPLAINT SAMPLE PICTURES AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
NEEDLE DID NOT COME OUT AFTER INJECTED THE MEDICATION TO OUTER THIGH AND DIDN'T HEAR ANY CLICK SOUND [DEVICE FAILURE] , NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 27-OCT-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA A VOICE MAIL AND A TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTO-INJECTOR. ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: 0115-1694-30, BATCH NO: G250804X, EXP DATE: 30-APR-2027) VIA INTRAMUSCULAR ROUTE FOR ALLERGIC REACTION AND RASH. CONCURRENT CONDITIONS INCLUDED ALLERGIC REACTION AND RASH. 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 (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION FROM PHARMACY AND ON THE SAME DATE, THE PATIENT USED HER FIRST EPIPEN DURING AN ALLERGIC REACTION IT WORKED FINE FOR HER. ON (B)(6) 2025, THE PATIENT EXPERIENCED RASH AND SHE USED HER SECOND EPIPEN AND OBSERVED THAT THE NEEDLE DID NOT COME OUT AFTER SHE INJECTED THE MEDICATION TO OUTER THIGH AND STATED THAT SHE DIDN'T HEAR ANY CLICK SOUND. PATIENT DENIED PROVIDING COMPLAINT SAMPLE PICTURES AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE 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 18-NOV-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 28 OCT 2025, AMNEAL RECEIVED A COMPLAINT FOR AN EPINEPHRINE AUTO-INJECTOR 0.3 MG (LOT G250804X) REPORTING NEEDLE DIDN¿T COME OUT. THE COMPLAINT WAS CATEGORIZED AS FAILURE TO FIRE. A PFIZER CMO INVESTIGATION WAS NOT REQUIRED, AS THE ISSUE RELATED TO ASSEMBLY AND PACKAGING AT PHILLIPS (PMM). PHILLIPS INVESTIGATION FOR LOT G250804X FOUND NO DEFECTS. ALL IN-PROCESS AND FINAL RELEASE TESTING MET SPECIFICATIONS, NO DEVIATIONS WERE IDENTIFIED, AND THE RETAIN SAMPLE FUNCTIONED PROPERLY. FAILURE TO FIRE WAS NOT CONFIRMED. AMNEALS EVALUATION OF THE RETURNED SAMPLE SHOWED THE SHEATH AND SHEATH REMOVER WERE MISSING, AND THE CARTRIDGE NEEDLE HUB WAS ALREADY ACTIVATED WITH PARTIAL SOLUTION LOSS, INDICATING ACTIVATION OCCURRED IN THE FIELD. THE FIRING MECHANISM WAS INTACT AND UNFIRED, AND FUNCTIONAL TESTING CONFIRMED THE DEVICE FIRED NORMALLY, WITH NEEDLE EXTENSION WITHIN SPECIFICATION. COMPLAINT WAS NOT CONFIRMED, AND A DEVICE MALFUNCTION WAS NOT IDENTIFIED. USER HANDLING ERROR REMAINS A PLAUSIBLE FACTOR. THIS WAS THE FIRST UNCONFIRMED COMPLAINT FOR LOT G250804X. OVER THE PAST 24 MONTHS, 14 SIMILAR COMPLAINTS WERE REPORTED OUT OF 4534153 UNITS (0.00030%), WITH 0 CONFIRMED FAILURES. NO TRENDS, QUALITY CONCERNS, OR IFU/LABELING GAPS WERE IDENTIFIED. CURRENT INSTRUCTIONS ARE ADEQUATE AND FDA-APPROVED. CONCLUSION: DEVICE OPERATED AS DESIGNED; NO BATCH-RELATED DEFECT IDENTIFIED. ROOT CAUSE UNDETERMINED, WITH USER ERROR THE MOST LIKELY CONTRIBUTOR. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE 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. FOLLOW-UP (#2) INFORMATION WAS RECEIVED ON 23-DEC-2025 SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED FROM PATIENT VIA VOICEMAIL. ADDITIONAL INFORMATION INCLUDED PATIENT DOB, AGE, AND NARRATIVE WERE UPDATED ACCORDINGLY. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS 62 YEARS. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WITH EPINEPHRINE AUTO-INJECTOR. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
NEEDLE DID NOT COME OUT AFTER INJECTED THE MEDICATION TO OUTER THIGH AND DIDN'T HEAR ANY CLICK SOUND [DEVICE FAILURE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF ADVERSE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT IN A FEMALE PATIENT (AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 27-OCT-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA A VOICE MAIL AND A TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S EPINEPHRINE AUTO-INJECTOR. ON (B)(6) 2025, THE PATIENT WAS BEING TREATED WITH EPINEPHRINE AUTO-INJECTOR 0.3 MG (NDC: (B)(4), BATCH NO: G250804X, EXP DATE: 30-APR-2027) VIA INTRAMUSCULAR ROUTE FOR ALLERGIC REACTION AND RASH. CONCURRENT CONDITIONS INCLUDED ALLERGIC REACTION AND RASH. 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 (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION FROM PHARMACY AND ON THE SAME DATE, THE PATIENT USED HER FIRST EPIPEN DURING AN ALLERGIC REACTION IT WORKED FINE FOR HER. ON (B)(6) 2025, THE PATIENT EXPERIENCED RASH AND SHE USED HER SECOND EPIPEN AND OBSERVED THAT THE NEEDLE DID NOT COME OUT AFTER SHE INJECTED THE MEDICATION TO OUTER THIGH AND STATED THAT SHE DIDN'T HEAR ANY CLICK SOUND. PATIENT DENIED PROVIDING COMPLAINT SAMPLE PICTURES AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE 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 18-NOV-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 28 OCT 2025, AMNEAL RECEIVED A COMPLAINT FOR AN EPINEPHRINE AUTO-INJECTOR 0.3 MG (LOT G250804X) REPORTING NEEDLE DIDN¿T COME OUT. THE COMPLAINT WAS CATEGORIZED AS FAILURE TO FIRE. A PFIZER CMO INVESTIGATION WAS NOT REQUIRED, AS THE ISSUE RELATED TO ASSEMBLY AND PACKAGING AT PHILLIPS (PMM). PHILLIPS INVESTIGATION FOR LOT G250804X FOUND NO DEFECTS. ALL IN-PROCESS AND FINAL RELEASE TESTING MET SPECIFICATIONS, NO DEVIATIONS WERE IDENTIFIED, AND THE RETAIN SAMPLE FUNCTIONED PROPERLY. FAILURE TO FIRE WAS NOT CONFIRMED. AMNEALS EVALUATION OF THE RETURNED SAMPLE SHOWED THE SHEATH AND SHEATH REMOVER WERE MISSING, AND THE CARTRIDGE NEEDLE HUB WAS ALREADY ACTIVATED WITH PARTIAL SOLUTION LOSS, INDICATING ACTIVATION OCCURRED IN THE FIELD. THE FIRING MECHANISM WAS INTACT AND UNFIRED, AND FUNCTIONAL TESTING CONFIRMED THE DEVICE FIRED NORMALLY, WITH NEEDLE EXTENSION WITHIN SPECIFICATION. COMPLAINT WAS NOT CONFIRMED, AND A DEVICE MALFUNCTION WAS NOT IDENTIFIED. USER HANDLING ERROR REMAINS A PLAUSIBLE FACTOR. THIS WAS THE FIRST UNCONFIRMED COMPLAINT FOR LOT G250804X. OVER THE PAST 24 MONTHS, 14 SIMILAR COMPLAINTS WERE REPORTED OUT OF (B)(4) UNITS ((B)(4)), WITH (B)(4) CONFIRMED FAILURES. NO TRENDS, QUALITY CONCERNS, OR IFU/LABELING GAPS WERE IDENTIFIED. CURRENT INSTRUCTIONS ARE ADEQUATE AND FDA-APPROVED. CONCLUSION: DEVICE OPERATED AS DESIGNED; NO BATCH-RELATED DEFECT IDENTIFIED. ROOT CAUSE UNDETERMINED, WITH USER ERROR THE MOST LIKELY CONTRIBUTOR. LAST ACTION TAKEN WITH EPINEPHRINE AUTO-INJECTOR IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF EVENTS DEVICE FAILURE 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 |
|---|---|---|---|---|---|---|---|
| 2096 | ADRENACLICK | TYPE 2 | PQX | PHILLIPS-MEDISIZE LLC | G250804X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Female | Other |