TWINJECT/ADRENACLICK
Report
- Report Number
- 3002919960-2024-00038
- Event Type
- Malfunction
- Date Received
- September 19, 2024
- Date of Event
- September 6, 2024
- Report Date
- October 18, 2024
- 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 OF AUTOINJECTOR DURING ANAPHYLAXIS REACTION [DEVICE FAILURE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF 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 EXPERIENCE WAS NOT REPORTED. ON (B)(6)2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT¿S CO-WORKER VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) 0.3 MG (NDC: 0115-1694-30, BATCH/LOT: G230711X, EXPIRATION DATE: FEB-2025, SERIAL NUMBER: NOT PROVIDED) (DOSE AND FREQUENCY WERE NOT PROVIDED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITION INCLUDES ANAPHYLACTIC REACTION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG AND LABORATORY TESTS USE WERE NOT REPORTED. IT WAS REPORTED THAT ON AN UNKNOWN DATE OF 2024 CONSUMER RECEIVED A SEALED MEDICATION BOX FROM THE PHARMACY. ON (B)(6) 2024 WHILE USING SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT FROM THE AUTOINJECTOR AND CONFIRMED THAT SHE USED THE SECOND INJECTION, AND IT WORKED FINE. UPON ASKING ADVERSE EVENTS DETAILS, NURSE STATED THAT ON AN UNKNOWN DATE OF (B)(6) 2024, CONSUMER EXPERIENCED ANAPHYLACTIC REACTION, AND SHE USED THE FIRST EPINEPHRINE AUTOINJECTOR AND OBSERVED THAT THE NEEDLE DID NOT COME OUT WHILE INJECTING TO CONSUMER. FURTHER, SHE USED SECOND EPINEPHRINE INJECTION AND MENTIONED THAT IT WORKED FINE, SHE CONFIRMED THAT CONSUMER VISITED HOSPITAL AND ADMITTED INTO EMERGENCY ROOM. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER CAUSALITY FOR THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON (B)(6) 2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON (B)(6) 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G230711X, ¿NEEDLE DID NOT COME OUT FROM THE INJECTOR¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE ¿DEFECTIVE INJECTOR¿. A CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY AND PACKAGING AT THE CPO PHILLIPS (PMM). PHILLIPS PERFORMED AN INVESTIGATION OF THE SUBJECT LOT. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. THE LOT MET ALL ACCEPTANCE CRITERIA BEFORE RELEASE AND DISTRIBUTION. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED FOR LOT G230711X FOR THE PAST 24 MONTHS. THE ONE OTHER COMPLAINT WAS INVESTIGATION AND DETERMINED MANUFACTURING WAS NOT CAUSAL ON THE REPORTED EVENT. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿DEFECTIVE INJECTOR¿ IN THE PAST 24 MONTHS. NONE OF THE (B)(4) SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. NOTE COMPLAINTS ARE ASSIGNED THE SUB-TYPE OF DEFECTIVE INJECTOR WHEN DETAIL SURROUNDING THE EVENT LACK DETAILS TO DETERMINE A MORE SPECIFIC COMPLAINT SUB-TYPE. BASED ON THE RETAIN REVIEW AND TESTING, THE RETAIN CONFORMED, THE REPORTED COMPLAINT OF WAS NOT CONFIRMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE REPORTER PROVIDED ONE (1) PHOTO OF THE COMPLAINT SAMPLE. THE PHOTO CONTAINED THE FOLLOWING: QUANTITY (B)(4) 0.3 MG EPINEPHRINE AUTO-INJECTOR LOT G230711X EXP FEB 2025. THERE WERE NO BLUE CAPS (SHEATH REMOVER AND SAFETY CAP) IN THE PHOTO OR AFFIXED ON THE DEVICE. THE IMAGE WAS POSITIONED WHEREAS THE LOT NUMBER AND EXP COULD BE READ. THE NEEDLE WAS OBSERVED PROJECTING FROM THE RED NOSE CAP. THE DEVICE WAS IN A FIRED STATE AS THE CARPUJECT INSIDE THE DEVICE WAS ADVANCED TOWARDS THE RED NOSE CAP AND THE NEEDLE WAS PROJECTING FROM THE NOSE CAP. ALL EVIDENCE OF A FIRED DEVICE. THERE WERE NO DEFECTS OBSERVED BASED ON THE PHOTO PROVIDED. BASED ON THE PHOTO PROVIDED FOR THE REPORTED COMPLAINT OF ¿NEEDLE DID NOT COME OUT FORM THE INJECTOR¿ WAS NOT CONFIRMED AS THE DEVICE WAS IN A FIRED STATE. EVIDENCE OF THE DEVICE BEING FIRED WAS THE CARPUJECT ADVANCED INSIDE THE DEVICE AND THE NEEDLE WAS PROJECTING FROM THE RED NOSE CAP. PER THE INSTRUCTIONS FOR USE (IFU), ¿THE INJECTION IS COMPLETE AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICINE IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEPS. BASED ON THE PHOTO PROVIDED THE DEVICE WAS IN A FIRED STATE. THIS IS CONTRADICTORY TO THE REPORTED COMPLAINT OF ¿NEEDLE DID NOT COME OUT FROM THE INJECTOR¿ AND THE QUESTIONNAIRE STATING THE NEEDLE WAS NOT VISIBLE AFTER INJECTION. AS SUCH A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG, LOT G230711X FOR THE COMPLAINT CATEGORY -¿DEFECTIVE INJECTOR¿, FOR THE REPORTED COMPLAINT DETERMINED THE MANUFACTURING, ASSEMBLY OR PACKAGING DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. A RETAIN REVIEW WAS PERFORMED AND THE PRODUCT CONFORMED. BASED ON THE PHOTO PROVIDED FOR THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WAS IN A FIRED STATE. A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED DUE TO THE FACT THE PHOTO PROVIDED SHOWED A DEVICE IN A FIRED STATE, WHEREAS THE REPORTED COMPLAINT WAS FOR ¿NEEDLE DID NOT COME OUT FORM THE INJECTOR¿ IT IS UNKNOWN IF THE DEVICE IN THE PHOTO IS THE DEFECTIVE INJECTOR OR THE SECOND DEVICE USED WHERE THERE WAS NO REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER CAUSALITY FOR THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT REPORTED. 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.
NEEDLE DID NOT COME OUT OF AUTOINJECTOR DURING ANAPHYLAXIS REACTION. [DEVICE FAILURE]. WHEN TRYING TO ADMINISTER AN EPIPEN DID NOT WORK AS IT SHOULD. WHEN TRYING TO PUT CAPS BACK ON THE EPIPEN WENT OFF. [DEVICE OPERATIONAL ISSUE] . NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF 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 EXPERIENCE WAS NOT REPORTED. ON 09-SEP-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT¿S CO-WORKER VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) 0.3 MG (NDC: 0115-1694-30, BATCH/LOT: G230711X, EXPIRATION DATE: FEB-2025, SERIAL NUMBER: NOT PROVIDED) (DOSE AND FREQUENCY WERE NOT PROVIDED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITION INCLUDES ANAPHYLACTIC REACTION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG AND LABORATORY TESTS USE WERE NOT REPORTED. IT WAS REPORTED THAT ON AN UNKNOWN DATE OF 2024 CONSUMER RECEIVED A SEALED MEDICATION BOX FROM THE PHARMACY. ON (B)(6) 2024 WHILE USING SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT FROM THE AUTOINJECTOR AND CONFIRMED THAT SHE USED THE SECOND INJECTION, AND IT WORKED FINE. UPON ASKING ADVERSE EVENTS DETAILS, NURSE STATED THAT ON AN UNKNOWN DATE OF (B)(6) 2024, CONSUMER EXPERIENCED ANAPHYLACTIC REACTION, AND SHE USED THE FIRST EPINEPHRINE AUTOINJECTOR AND OBSERVED THAT THE NEEDLE DID NOT COME OUT WHILE INJECTING TO CONSUMER. FURTHER, SHE USED SECOND EPINEPHRINE INJECTION AND MENTIONED THAT IT WORKED FINE, SHE CONFIRMED THAT CONSUMER VISITED HOSPITAL AND ADMITTED INTO EMERGENCY ROOM. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER CAUSALITY FOR THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 19-SEP-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 09 SEP 24, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G230711X, ¿NEEDLE DID NOT COME OUT FROM THE INJECTOR¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE ¿DEFECTIVE INJECTOR¿. A CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY AND PACKAGING AT THE CPO PHILLIPS (PMM). PHILLIPS PERFORMED AN INVESTIGATION OF THE SUBJECT LOT. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. THE LOT MET ALL ACCEPTANCE CRITERIA BEFORE RELEASE AND DISTRIBUTION. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED FOR LOT G230711X FOR THE PAST 24 MONTHS. THE ONE OTHER COMPLAINT WAS INVESTIGATION AND DETERMINED MANUFACTURING WAS NOT CAUSAL ON THE REPORTED EVENT. THERE HAVE BEEN THIRTY-SEVEN (37) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿DEFECTIVE INJECTOR¿ IN THE PAST 24 MONTHS. NONE OF THE 37 SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. NOTE COMPLAINTS ARE ASSIGNED THE SUB-TYPE OF DEFECTIVE INJECTOR WHEN DETAIL SURROUNDING THE EVENT LACK DETAILS TO DETERMINE A MORE SPECIFIC COMPLAINT SUB-TYPE. BASED ON THE RETAIN REVIEW AND TESTING, THE RETAIN CONFORMED, THE REPORTED COMPLAINT OF WAS NOT CONFIRMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE REPORTER PROVIDED ONE (1) PHOTO OF THE COMPLAINT SAMPLE. THE PHOTO CONTAINED THE FOLLOWING: QUANTITY ONE (1) 0.3 MG EPINEPHRINE AUTO-INJECTOR LOT G230711X EXP FEB 2025. THERE WERE NO BLUE CAPS (SHEATH REMOVER AND SAFETY CAP) IN THE PHOTO OR AFFIXED ON THE DEVICE. THE IMAGE WAS POSITIONED WHEREAS THE LOT NUMBER AND EXP COULD BE READ. THE NEEDLE WAS OBSERVED PROJECTING FROM THE RED NOSE CAP. THE DEVICE WAS IN A FIRED STATE AS THE CARPUJECT INSIDE THE DEVICE WAS ADVANCED TOWARDS THE RED NOSE CAP AND THE NEEDLE WAS PROJECTING FROM THE NOSE CAP. ALL EVIDENCE OF A FIRED DEVICE. THERE WERE NO DEFECTS OBSERVED BASED ON THE PHOTO PROVIDED. BASED ON THE PHOTO PROVIDED FOR THE REPORTED COMPLAINT OF ¿NEEDLE DID NOT COME OUT FORM THE INJECTOR¿ WAS NOT CONFIRMED AS THE DEVICE WAS IN A FIRED STATE. EVIDENCE OF THE DEVICE BEING FIRED WAS THE CARPUJECT ADVANCED INSIDE THE DEVICE AND THE NEEDLE WAS PROJECTING FROM THE RED NOSE CAP. PER THE INSTRUCTIONS FOR USE (IFU), ¿THE INJECTION IS COMPLETE AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICINE IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEPS. BASED ON THE PHOTO PROVIDED THE DEVICE WAS IN A FIRED STATE. THIS IS CONTRADICTORY TO THE REPORTED COMPLAINT OF ¿NEEDLE DID NOT COME OUT FROM THE INJECTOR¿ AND THE QUESTIONNAIRE STATING THE NEEDLE WAS NOT VISIBLE AFTER INJECTION. AS SUCH A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG, LOT G230711X FOR THE COMPLAINT CATEGORY -¿DEFECTIVE INJECTOR¿, FOR THE REPORTED COMPLAINT DETERMINED THE MANUFACTURING, ASSEMBLY OR PACKAGING DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. A RETAIN REVIEW WAS PERFORMED AND THE PRODUCT CONFORMED. BASED ON THE PHOTO PROVIDED FOR THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WAS IN A FIRED STATE. A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED DUE TO THE FACT THE PHOTO PROVIDED SHOWED A DEVICE IN A FIRED STATE, WHEREAS THE REPORTED COMPLAINT WAS FOR ¿NEEDLE DID NOT COME OUT FORM THE INJECTOR¿ IT IS UNKNOWN IF THE DEVICE IN THE PHOTO IS THE DEFECTIVE INJECTOR OR THE SECOND DEVICE USED WHERE THERE WAS NO REPORTED COMPLAINT. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER CAUSALITY FOR THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT REPORTED. 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. FOLLOW UP (#2) AND (#3) INFORMATION WAS RECEIVED ON 06-OCT-2024 AND 08-OCT-24: SIGNIFICANT FOLLOW UP (#2) WAS RECEIVED FROM PATIENT¿S CO-WORKER (OCCUPATION: NURSE) VIA REGULATORY AUTHORITY, WITH REFERENCE NUMBER AER# (B)(4). NEW INFORMATION INCLUDED; PRODUCT DETAILS (EXP DATE) AND ADDITIONAL EVENT (DEVICE OPERATIONAL ISSUE) WAS ADDED AND NARRATIVE UPDATED. SIGNIFICANT FOLLOW UP (#3) INFORMATION RECEIVED ON 08-OCT-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) 0.3 MG (NDC: 0115-1694-49, BATCH/LOT: G230711X, EXPIRATION DATE: 01-FEB-2025) FOR ANAPHYLACTIC REACTION. IT WAS REPORTED THAT, WHEN TRYING TO ADMINISTER AN EPIPEN THE EPIPEN DID NOT WORK AS IT SHOULD. THEN WHEN TRYING TO PUT CAPS BACK ON THE EPIPEN WENT OFF. ON 09-SEP-24, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G230711X, NEEDLE DID NOT COME OUT FROM THE INJECTOR. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE ¿DEFECTIVE INJECTOR¿. A CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY AND PACKAGING AT THE CPO PHILLIPS (PMM). PHILLIPS PERFORMED AN INVESTIGATION OF THE SUBJECT LOT. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT COMP 2024 4476 AND THE MANUFACTURING PROCESS AT PMM. ALL IN-PROCESS TESTING MET ACCEPTABLE CRITERIA, THERE WERE NO DEVIATIONS OR DISCREPANCIES FOUND DURING ASSEMBLY OF THIS LOT THAT COULD HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. THE LOT MET ALL ACCEPTANCE CRITERIA BEFORE RELEASE AND DISTRIBUTION. THERE HAS BEEN ONE OTHER COMPLAINT REPORTED FOR LOT G230711X FOR THE PAST 24 MONTHS. THE ONE OTHER COMPLAINT WAS INVESTIGATION AND DETERMINED MANUFACTURING WAS NOT CAUSAL ON THE REPORTED EVENT. THERE HAVE BEEN THIRTY-SEVEN (37) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY DEFECTIVE INJECTOR IN THE PAST 24 MONTHS. NONE OF THE 37 SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. NOTE COMPLAINTS ARE ASSIGNED THE SUB-TYPE OF DEFECTIVE INJECTOR WHEN DETAIL SURROUNDING THE EVENT LACK DETAILS TO DETERMINE A MORE SPECIFIC COMPLAINT SUB-TYPE. BASED ON THE RETAIN REVIEW AND TESTING, THE RETAIN CONFORMED, THE REPORTED COMPLAINT OF WAS NOT CONFIRMED. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODE IS CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE REPORTER PROVIDED ONE (1) PHOTO OF THE COMPLAINT SAMPLE. THE PHOTO CONTAINED THE FOLLOWING:QUANTITY ONE (1) 0.3 MG EPINEPHRINE AUTO-INJECTOR LOT G230711X EXP FEB 2025. THERE WERE NO BLUE CAPS (SHEATH REMOVER AND SAFETY CAP) IN THE PHOTO OR AFFIXED ON THE DEVICE. THE IMAGE WAS POSITIONED WHEREAS THE LOT NUMBER AND EXP COULD BE READ. THE NEEDLE WAS OBSERVED PROJECTING FROM THE RED NOSE CAP. THE DEVICE WAS IN A FIRED STATE AS THE CARPUJECT INSIDE THE DEVICE WAS ADVANCED TOWARDS THE RED NOSE CAP AND THE NEEDLE WAS PROJECTING FROM THE NOSE CAP. ALL EVIDENCE OF A FIRED DEVICE. THERE WERE NO DEFECTS OBSERVED BASED ON THE PHOTO PROVIDED. BASED ON THE PHOTO PROVIDED FOR THE REPORTED COMPLAINT OF ¿NEEDLE DID NOT COME OUT FORM THE INJECTOR¿ WAS NOT CONFIRMED AS THE DEVICE WAS IN A FIRED STATE. EVIDENCE OF THE DEVICE BEING FIRED WAS THE CARPUJECT ADVANCED INSIDE THE DEVICE AND THE NEEDLE WAS PROJECTING FROM THE RED NOSE CAP. THE COMPLAINT SAMPLE WAS RETURNED ON 20-SEP-2024 AND INSPECTED ON 01-OCT-2024 FROM THE SAMPLE RETURN KIT PROVIDED BY IMPAX - AMNEAL. ONE (1) 0.3 MG AUTO-INJECTOR WAS RETURNED, WHICH INCLUDED A SAMPLE FROM LOT G230711X EXP FEB-2025. BASED ON THE COMPLAINT SAMPLE EVALUATION FOR THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE DEVICE HAD BEEN FIRED, DELIVERED A DOSE AND WAS ADMINISTERED TO A PATIENT. EVIDENCE THE DEVICE BEING FIRED AND DOSE DELIVERY WERE THE FOLLOWING; THE NEEDLE WAS PROJECTING FROM THE RED NOSE CAP, THE SPRING RELEASE TINES WERE NOT AFFIXED TO THE FIRING BUSHING, THE CARPUJECT HAD APPROXIMATELY 0.8 ML OF SOLUTION REMAINING AND THE DOSE ADJUSTMENT SCREW WAS IN CONTACT WITH THE STOP COLLAR. IN ADDITION, SKIN TISSUE RESIDUE WAS OBSERVED ON THE NEEDLE OF THE SAMPLE WHICH CONFIRMED THE DEVICE WAS ADMINISTERED TO THE PATIENT. THERE WERE NO DEFECTS IDENTIFIED WHICH WOULD HAVE PREVENTED THE DEVICE FROM FIRING AT THE TIME OF USE. PER THE INSTRUCTIONS FOR USE (IFU), ¿THE INJECTION IS COMPLETE AND YOU HAVE RECEIVED THE CORRECT DOSE OF THE MEDICINE IF YOU SEE THE NEEDLE STICKING OUT OF THE RED TIP. IF YOU DO NOT SEE THE NEEDLE REPEAT STEPS. TO AVOID AN ACCIDENTAL INJECTION, NEVER PUT YOUR THUMB, FINGERS OR HAND OVER THE RED TIP. IF AN ACCIDENTAL INJECTION HAPPENS, GET MEDICAL HELP RIGHT AWAY. BASED ON THE PHOTO AND COMPLAINT SAMPLE PROVIDED THE DEVICE WAS IN A FIRED STATE AND SKIN TISSUE ON THE DEVICE IS EVIDENCE THE DEVICE WAS ADMINISTERED TO THE PATIENT. THIS IS CONTRADICTORY TO THE REPORTED COMPLAINT OF ¿NEEDLE DID NOT COME OUT FROM THE INJECTOR¿ AND THE QUESTIONNAIRE STATING THE NEEDLE WAS NOT VISIBLE AFTER INJECTION. IN ADDITION,THE REPORTER THEN STATED ¿WHEN TRYING TO ADMINISTER AN EPIPEN THE EPIPEN DID NOT WORK AS IT SHOULD. THEN WHEN TRYING TO PUT CAPS BACK ON THE EPIPEN WENT OFF. BASED ON THE COMPLAINT SAMPLE EVALUATION ALL EVIDENCE CONCLUDED THAT THE DEVICE WAS ADMINISTERED AND DELIVERED A DOSE. DUE TO CONFLICTING INFORMATION PROVIDED OF THE REPORTED EVENT A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG, LOT G230711X FOR THE COMPLAINT CATEGORY ¿ ¿DEFECTIVE INJECTOR¿, FOR THE REPORTED COMPLAINT DETERMINED THE MANUFACTURING, ASSEMBLY OR PACKAGING DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. A RETAIN REVIEW WAS PERFORMED AND THE PRODUCT CONFORMED. BASED ON THE PHOTO PROVIDED AND COMPLAINT SAMPLE EVALUATION, THE REPORTED COMPLAINT WAS NOT CONFIRMED AS THE DEVICE WAS IN A FIRED STATE, HAD BEEN ADMINISTERED TO A PATIENT AND DELIVERED A DOSE. BASED ON THE COMPLAINT SAMPLE EVALUATION AND CONFLICTING INFORMATION PROVIDED OF THE REPORTED EVENT A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE FAILURE, DEVICE OPERATIONAL ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE, DEVICE OPERATIONAL ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER CAUSALITY FOR THE EVENTS DEVICE FAILURE, DEVICE OPERATIONAL ISSUE AND NO ADVERSE EVENT WAS NOT REPORTED. 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.
NEEDLE DID NOT COME OUT OF AUTOINJECTOR DURING ANAPHYLAXIS REACTION [DEVICE FAILURE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF 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 EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT¿S CO-WORKER VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) 0.3 MG (NDC: (B)(4), BATCH/LOT: G230711X, EXPIRATION DATE: FEB-2025, SERIAL NUMBER: NOT PROVIDED) (DOSE AND FREQUENCY WERE NOT PROVIDED) FOR ANAPHYLACTIC REACTION. CONCURRENT CONDITION INCLUDES ANAPHYLACTIC REACTION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, RECREATIONAL DRUG AND LABORATORY TESTS USE WERE NOT REPORTED. IT WAS REPORTED THAT ON AN UNKNOWN DATE OF 2024 CONSUMER RECEIVED A SEALED MEDICATION BOX FROM THE PHARMACY. ON (B)(6) 2024 WHILE USING SHE OBSERVED THAT THE NEEDLE DID NOT COME OUT FROM THE AUTOINJECTOR AND CONFIRMED THAT SHE USED THE SECOND INJECTION, AND IT WORKED FINE. UPON ASKING ADVERSE EVENTS DETAILS, NURSE STATED THAT ON AN UNKNOWN DATE OF (B)(6) 2024, CONSUMER EXPERIENCED ANAPHYLACTIC REACTION, AND SHE USED THE FIRST EPINEPHRINE AUTOINJECTOR AND OBSERVED THAT THE NEEDLE DID NOT COME OUT WHILE INJECTING TO CONSUMER. FURTHER, SHE USED SECOND EPINEPHRINE INJECTION AND MENTIONED THAT IT WORKED FINE, SHE CONFIRMED THAT CONSUMER VISITED HOSPITAL AND ADMITTED INTO EMERGENCY ROOM. LAST ACTION TAKEN WITH EPINEPHRINE IN RELATION TO DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE FAILURE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER CAUSALITY FOR THE EVENTS DEVICE FAILURE AND NO ADVERSE EVENT WAS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1671479 | TWINJECT/ADRENACLICK | TYPE 2 | PQX | G230711X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Hospitalization| O |