TWINJECT/ADRENACLICK
Report
- Report Number
- 3002919960-2024-00030
- Event Type
- Malfunction
- Date Received
- July 15, 2024
- Report Date
- July 30, 2024
- Product Code
- PQX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE NEEDLE DIDN'T GO IN THE NEEDLE DIDN'T DISENGAGE [DEVICE MALFUNCTION] NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE MALFUNCTION 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 VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE INJECTION, AUTO-INJECTOR). ON AN UNKNOWN DATE, THE PATIENT WAS USING TWINJECT 0.3 (EPINEPHRINE INJECTION, AUTO-INJECTOR) (BATCH/LOT: G230505X AND EXPIRATION DATE: JAN-2025) (STRENGTH, DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR UNKNOWN INDICATION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, CONCURRENT CONDITION, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT TRIED TO ADMINISTER THE DRUG LAST NIGHT (AT THE TIME OF THE REPORT) AND THE NEEDLE DIDN'T GO IN THE NEEDLE DIDN'T DISENGAGE THE ONLY THING THAT WAS STICKING OUT WAS THE PLASTIC WHITE THING AND THEN YOU CAN SEE THE NEEDLE INSIDE OF IT. SHE ENDED UP AT THE ER AND ALL THAT GOOD STUFF AND AMBULANCE AND YOU KNOW USING ALERT AND STUFF LIKE THAT BUT THIS EPIPEN DID NOT WORK. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE MALFUNCTION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MALFUNCTION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MALFUNCTION AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
THE NEEDLE DIDN'T GO IN THE NEEDLE DIDN'T DISENGAGE [DEVICE MALFUNCTION] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE MALFUNCTION 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 0(B)(6) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE INJECTION, AUTO-INJECTOR). ON AN UNKNOWN DATE, THE PATIENT WAS USING TWINJECT 0.3 (EPINEPHRINE INJECTION, AUTO-INJECTOR) (BATCH/LOT: G230505X AND EXPIRATION DATE: JAN-2025) (STRENGTH, DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR UNKNOWN INDICATION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, MEDICAL HISTORY, CONCURRENT CONDITION, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT TRIED TO ADMINISTER THE DRUG LAST NIGHT (AT THE TIME OF THE REPORT) AND THE NEEDLE DIDN'T GO IN THE NEEDLE DIDN'T DISENGAGE THE ONLY THING THAT WAS STICKING OUT WAS THE PLASTIC WHITE THING AND THEN YOU CAN SEE THE NEEDLE INSIDE OF IT. SHE ENDED UP AT THE ER AND ALL THAT GOOD STUFF AND AMBULANCE AND YOU KNOW USING ALERT AND STUFF LIKE THAT BUT THIS THIS EPIPEN DID NOT WORK. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE MALFUNCTION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MALFUNCTION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MALFUNCTION AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 23-JUL-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 03 JUL 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G230505X, ¿EPIPEN DID NOT WORK¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR ¿SHEATH MOT REMOVED BY SHEATH REMOVER¿. THE CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY OF THE DEVICE AT PHILLIPS. AN INVESTIGATION WAS PERFORMED BY PHILLIPS ON THE SUBJECT LOT. AFTER REVIEW OF THE MANUFACTURING CONTROLS IN PLACE, PMM DOES SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4), HOWEVER, NO ROOT CAUSE WAS IDENTIFIED. (B)(4), NOTED FOR THE WITH A FAILURE ON ONE DEVICE OBSERVED FOR THE CHECK, ¿SHEATH REMOVER DOES NOT REMOVE NEEDLE SHEATH¿. UPON AGREEMENT OF AMNEAL AND PMM, TIER II, AN ADDITIONAL (B)(4) SAMPLES WERE ADVISED AS NO ROOT CAUSE WAS IDENTIFIED UPON EVALUATING THE FAILED DEVICE, AND TIER II WAS COMPLETED WITH PASSING RESULTS. THE LOT MET ALL ACCEPTANCE CRITERIA BEFORE RELEASE AND DISTRIBUTION. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR LOT G230505X FOR THE PAST 24 MONTHS. THERE HAVE BEEN TWELVE (12) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿SHEATH NOT REMOVED BY SHEATH REMOVER¿ IN THE PAST 24 MONTHS. NONE OF THE 12 SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. BASED ON THE RETAIN REVIEW AND TESTING THE RETAIN TESTED 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 RETURNED FOR EVALUATION. THE INSTRUCTIONS FOR USE (IFU) WERE REVIEWED AND THERE ARE ADEQUATE INSTRUCTIONS FOR ADMINISTRATION. AS PER THE IFU, ¿PULL OFF BOTH BLUE CAPS. YOU WILL NOW SEE A RED TIP. GRASP EPINEPHRINE INJECTION IN YOUR FIST WITH RED TIP POINTING DOWNWARD. (NOTE, THERE IS A PICTURE IN THE IFU SHOWING BOTH BLUE CAPS BEING REMOVED. THE SHEATH REMOVER PHOTOS SHOW THE SHEATH BULB TIP AS PART OF THE SHEATH REMOVER.) THE NEEDLE COMES OUT OF THE RED TIP. TO AVOID ACCIDENTAL INJECTION, NEVER PUT YOUR THUMB, FINGERS OF HAND OVER THE RED TIP. IF ACCIDENTAL INJECTION HAPPENS, GET MEDICAL HELP RIGHT AWAY. PUT THE RED TIP AGAINST THE MIDDLE OF THE OUTER THIGH AT A 90 DEGREE ANGLE. PRESS DOWN HARD AND HOLD FIRMLY AGAINST THIGH FOR APPROXIMATELY TEN (10) SECONDS TO DELIVER THE MEDICINE. ONLY INJECT INTO THE MIDDLE OF THE OUTER THIGH. CHECK THE RED TIP. 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.¿ IF ADDITION, THERE ARE INSTRUCTIONS FOR AFTER USE DISPOSAL. AS PER THE IFU, ¿CAREFULLY COVER THE NEEDLE WITH THE CARRYING CASE.¿ (NOTE, THERE IS A PICTURE IN THE IFU SHOWING THE DEVICE RED NEEDLE TIP WITH EXPOSED NEEDLE) AS THE DETAILS PROVIDED FOR THIS COMPLAINT WERE INSUFFICIENT TO DETERMINE CAUSE AND THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED.THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG, LOT G230505X FOR THE COMPLAINT CATEGORY - SHEATH NOT REMOVED BY SHEATH REMOVER; FOR THE REPORTED COMPLAINT ¿EPIPEN DID NOT WORK¿ DETERMINED THE MANUFACTURING OR ASSEMBLY DID NOT ATTRIBUTE TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT WAS NOT CONFIRMED IN THE RETAIN REVIEW AS THE SAMPLE TESTED CONFORMED. THE COMPLAINT SAMPLE WAS NOT RETURNED AS SUCH THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE LOT RELEASED TO MARKET WAS MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND SPECIFICATIONS. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE MALFUNCTION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MALFUNCTION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MALFUNCTION AND NO ADVERSE EVENT WITH TWINJECT. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 257899 | TWINJECT/ADRENACLICK | TYPE 2 | PQX | G230505X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female | Other |