ADRENACLICK
Report
- Report Number
- 3002919960-2025-00034
- Event Type
- Malfunction
- Date Received
- September 25, 2025
- Date of Event
- January 1, 2025
- Report Date
- October 9, 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
WHEN OPENED THE CARRYING CASE FOR CHECKING THE EPINEPHRINE INJECTION, BLUE CAPS WERE OFF FROM THE INJECTOR AND THE NEEDLE WAS BEND TO 90 DEGREES/PRODUCT WAS ALL FALLING THE PART [DEVICE OPERATIONAL ISSUE] , BLUE CAPS WERE OFF FROM THE INJECTOR AND THE NEEDLE WAS BEND TO 90 DEGREES/PRODUCT WAS ALL FALLING THE PART [NEEDLE ISSUE] , NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER, RACE WAS NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 09-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT¿S MOTHER VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE). ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 11-SEP-2025 FROM THE PATIENT¿S MOTHER VIA A TELEPHONIC CALL AND EMAIL. NEW INFORMATION INCLUDED; PATIENT DETAILS (AGE, HEIGHT, AND WEIGHT) PRODUCT DETAILS (LOT NO, EXP DATE, NDC, SERIAL NO) WERE ADDED. THIS CASE PERTAINS TO A 22-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS PRESCRIBED WITH EPINEPHRINE AUTO-INJECTOR (LOT NO: G250110X, EXPIRATION DATE: 30-SEP-2026, NDC: 0115-1694-49, SERIAL NUMBER: (B)(6) (DOSE AND FREQUENCY WERE NOT REPORTED) FOR ALLERGIES. THE PATIENT HAD ALLERGIES. CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY. ON AN UNKNOWN DATE OF 2025, ONE OF THE SCHOOL NURSES FROM PATIENT¿S SCHOOL OPENED THE CARRYING CASE FOR CHECKING THE EPINEPHRINE INJECTION, NURSE OBSERVED THAT BLUE CAPS WERE OFF FROM THE INJECTOR AND THE NEEDLE WAS BEND TO 90 DEGREES. REPORTER CONFIRMED THAT THE ISSUE DID NOT OCCUR DURING THE ANAPHYLAXIS REACTION AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENT OF DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT ASSESS THE CAUSALITY OF EVENT OF DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
WHEN OPENED THE CARRYING CASE FOR CHECKING THE EPINEPHRINE INJECTION, BLUE CAPS WERE OFF FROM THE INJECTOR AND THE NEEDLE WAS BEND TO 90 DEGREES/PRODUCT WAS ALL FALLING THE PART [DEVICE OPERATIONAL ISSUE], BLUE CAPS WERE OFF FROM THE INJECTOR AND THE NEEDLE WAS BEND TO 90 DEGREES/PRODUCT WAS ALL FALLING THE PART [NEEDLE ISSUE] , NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS SPONTANEOUS REPORT CONCERNS OF EVENTS DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER, RACE WAS NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 09-SEP-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT¿S MOTHER VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S ADRENACLICK (EPINEPHRINE). ADDITIONAL SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 11-SEP-2025 FROM THE PATIENT¿S MOTHER VIA A TELEPHONIC CALL AND EMAIL. NEW INFORMATION INCLUDED PATIENT DETAILS (AGE, HEIGHT, AND WEIGHT) PRODUCT DETAILS (LOT NO, EXP DATE, NDC, SERIAL NO) WERE ADDED. THIS CASE PERTAINS TO A 22-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS PRESCRIBED WITH EPINEPHRINE AUTO-INJECTOR (LOT NO: G250110X, EXPIRATION DATE: (B)(6) 2026, NDC: 0115-1694-49, SERIAL NUMBER: (B)(6) (DOSE AND FREQUENCY WERE NOT REPORTED) FOR ALLERGIES. THE PATIENT HAD ALLERGIES. CONCURRENT CONDITIONS, CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES AND SURGERIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE AND LABORATORY TESTS WERE NOT REPORTED. ON (B)(6) 2025, THE PATIENT RECEIVED A SEALED MEDICATION BOX FROM PHARMACY. ON AN UNKNOWN DATE OF 2025, ONE OF THE SCHOOL NURSES FROM PATIENT¿S SCHOOL OPENED THE CARRYING CASE FOR CHECKING THE EPINEPHRINE INJECTION, NURSE OBSERVED THAT BLUE CAPS WERE OFF FROM THE INJECTOR AND THE NEEDLE WAS BEND TO 90 DEGREES. REPORTER CONFIRMED THAT THE ISSUE DID NOT OCCUR DURING THE ANAPHYLAXIS REACTION AND REQUESTED FOR THE REPLACEMENT. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENT OF DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT ASSESS THE CAUSALITY OF EVENT OF DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION WAS RECEIVED ON 29-SEP-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THE COMPLAINT SAMPLE WAS NOT RETURNED AT THE TIME OF THE REPORT. THE INVESTIGATION CONFIRMED THAT ALL MANUFACTURING PROCESSES, IN-PROCESS TESTING (200 UNITS), AND FINAL RELEASE TESTING (50 COMPOSITE UNITS) FOR LOT G250110X WERE PERFORMED PER SPECIFICATION WITH NO ANOMALIES IDENTIFIED. EVALUATION OF RETAINED SAMPLES ALSO DEMONSTRATED PROPER FUNCTIONALITY WITH NO MECHANICAL OR FUNCTIONAL DEFECTS OBSERVED. HISTORICAL DATA REVIEW SHOWED ONE PRIOR COMPLAINT FOR THIS LOT WITHIN THE PAST 24 MONTHS, WITH THIS CASE REPRESENTING THE SECOND. ACROSS 253 BATCHES (4,647,734 DEVICES RELEASED) DURING THE SAME TIMEFRAME, THERE WERE 31 SIMILAR ¿DEFECTIVE INJECTOR¿ COMPLAINTS, YIELDING A FREQUENCY OF 0.00069%. THIS LOW RATE SUPPORTS THE ROBUSTNESS AND RELIABILITY OF THE MANUFACTURING PROCESS. A PFMEA REVIEW FURTHER CONFIRMED THAT THE FAILURE MODE IS CAPTURED AND APPROPRIATELY CONTROLLED WITHIN THE ASSEMBLY PROCESS. LABELING AND INSTRUCTIONS FOR USE (PI/PIL, 2-PACK CARTON, AND DEVICE WRAP LABEL) WERE REVIEWED AND FOUND TO PROVIDE CLEAR, FDA-APPROVED INSTRUCTIONS WITH ADEQUATE PICTORIALS FOR PREPARATION, ADMINISTRATION, AND DISPOSAL. NO LABELING CHANGES WERE DEEMED NECESSARY. WITH RESPECT TO THE REPORTED CONDITION, THE INVESTIGATION DETERMINED THAT BOTH BLUE SAFETY CAPS REQUIRE DELIBERATE REMOVAL AND WERE LIKELY REMOVED IN THE FIELD, WHILE THE BENT NEEDLE IS CONSISTENT WITH POST-INJECTION HANDLING ERROR RATHER THAN A MANUFACTURING OR DEVICE MALFUNCTION. IN SUMMARY, THE AVAILABLE EVIDENCE INDICATES THAT THE DEVICE HAD BEEN USED AND NOT PROPERLY DISPOSED OF. DUE TO THE LACK OF RETURNED SAMPLE AND LIMITED COMPLAINT DETAILS, A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED. HOWEVER, THE FINDINGS STRONGLY SUGGEST USER HANDLING CONTRIBUTED TO THE ISSUE. NO MANUFACTURING DEFECT WAS IDENTIFIED, AND NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT ASSESS THE CAUSALITY OF EVENTS DEVICE OPERATIONAL ISSUE, NEEDLE ISSUE AND NO ADVERSE EVENT WITH EPINEPHRINE. 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 |
|---|---|---|---|---|---|---|---|
| 1824182 | ADRENACLICK | TYPE 2 | PQX | PHILLIPS-MEDISIZE LLC | G250110X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Female | Other |