TWINJECT/ADRENACLICK
Report
- Report Number
- 3002919960-2024-00046
- Event Type
- Malfunction
- Date Received
- November 22, 2024
- Date of Event
- November 11, 2024
- Report Date
- December 16, 2024
- 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 FOR THE FIRST PEN [DEVICE FAILURE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE AND NO ADVERSE EVENT IN A 26-YEAR-OLD FEMALE PATIENT (RACE WAS NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS 26 YEARS. ON (B)(6) 2024, (B)(6) PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT¿S VIA TELEPHONIC CALL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED WHILE ON AMNEAL'S TWIN JECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH EPINEPHRINE INJECTION (AUTO-INJECTOR) 0.3 MG (NDC: 0115-1694-30, BATCH/LOT: G230603, EXPIRATION DATE: JAN-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 UNKNOWN DATE THEY RECEIVED SEALED MEDICATION FROM THE PHARMACY AND ON (B)(6) 2024, CONSUMER HAD AN ALLERGIC REACTION, AND SHE IMMEDIATELY TRIED TO USE THE FIRST PEN AND OBSERVED THAT THE NEEDLE DID NOT COME OUT FOR THE FIRST PEN AND IMMEDIATELY USED THE SECOND PEN WHICH WORKED FINE AND RECOVERED FROM ALLERGIC REACTION. FURTHER SHE REQUESTED REPLACEMENT AND AGREED TO RETURN THE DEFECTIVE PEN BACK TO US AND ALSO AGREED TO SEND COMPLAINT SAMPLE PICTURES. 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.
NEEDLE DID NOT COME OUT FOR THE FIRST PEN [DEVICE FAILURE] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE FAILURE AND NO ADVERSE EVENT IN A 26 YEARS OLD FEMALE PATIENT (RACE WAS NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS 26 YEARS. ON (B)(6) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE PATIENT¿S 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: G230603, EXPIRATION DATE: JAN-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 UNKNOWN DATE THEY RECEIVED SEALED MEDICATION FROM THE PHARMACY AND ON 11-NOV-2024, CONSUMER HAD AN ALLERGIC REACTION, AND SHE IMMEDIATELY TRIED TO USE THE FIRST PEN AND OBSERVED THAT THE NEEDLE DID NOT COME OUT FOR THE FIRST PEN AND IMMEDIATELY USED THE SECOND PEN WHICH WORKED FINE AND RECOVERED FROM ALLERGIC REACTION. FURTHER SHE REQUESTED REPLACEMENT AND AGREED TO RETURN THE DEFECTIVE PEN BACK TO US AND ALSO AGREED TO SEND COMPLAINT SAMPLE PICTURES. 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 04 DEC 2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 13 NOV 2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT G230603X, ¿NEEDLE DIDN'T COME OUT OF THE FIRST PEN¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE ¿SHEATH NOT REMOVED BY SHEATH REMOVER¿. 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 SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT PC- (B)(4) AND THE MANUFACTURING PROCESS AT PMM. THE SHEATH REMOVER REMOVED THE SHEATH FROM THE RESERVE SAMPLE AS INTENDED, THE RESERVE SAMPLE FIRED, THE NEEDLE CAME OUT MEETING THE NEEDLE LENGTH TOLERANCE AND DELIVERED THE CORRECT DOSE WITH NO ANOMALY. 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 COMPLAINT SAMPLE WAS REVIEWED WITH A SHEATH REMOVER CAVITY 14, THE SHEATH REMOVER REMOVED THE SHEATH WITH MINIMAL FORCE AND NO ANOMALY NOTED WITH THE COMPLAINT SAMPLE PER COMPLAINT SAMPLE INSPECTION. THERE HAS BEEN NO OTHER COMPLAINT REPORTED FOR LOT G230603X FOR THE PAST 24 MONTHS. THERE HAVE BEEN THIRTEEN (13) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿SHEATH NOT REMOVED BY SHEATH REMOVER¿ IN THE PAST 24 MONTHS. NONE OF THE 13 SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS OR COMPONENTS. 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 RETURNED ON 19 NOV 24 FROM THE SAMPLE RETURN KIT PROVIDED BY IMPAX - AMNEAL. ONE (1) 0.3 MG AUTO-INJECTOR WAS RETURNED, WHICH INCLUDED A SAMPLE FROM LOT G230603X EXP 2025. ONE (1) AUTO-INJECTOR WAS RETURNED IN A FIRED STATE. UPON INSPECTION THE DEVICE HAD BEEN FIRED, THE SAFETY CAP AND SHEATH REMOVER AND SHEATH WERE ATTACHED TO THE DEVICE. THE SHEATH WAS INSPECTED AND THERE WAS APPROXIMATELY 0.3ML OF SOLUTION INSIDE, THIS WAS EVIDENCE THAT THE SHEATH WAS NOT REMOVED BY THE USER. THE SHEATH REMOVER WAS ATTACHED OVER THE SHEATH AND THE SHEATH WAS PROTRUDING FROM THE SHEATH REMOVER AND RED NOSE CAP. IT APPEARED THAT THE SHEATH REMOVER AND SAFETY CAP HAD BEEN RE-INSTALLED TO THE DEVICE, AS BY DESIGN AN AUTO-INJECTOR WILL NOT FIRE WITH A SHEATH REMOVER AND SAFETY CAP IN PLACE ON THE DEVICE. BOTH BLUE CAPS MUST BE REMOVED TO FIRE THE DEVICE AND PROJECT THE NEEDLE. THE SAFETY CAP PREVENTS THE DEVICE FROM FIRING AS THE SAFETY CAP HAS AN INTERNAL PIN WHICH IS INSERTED INTO THE SPRING RELEASE, THIS PIN PREVENTS THE FIRING MECHANISM FROM FIRING. THE SAFETY CAP WAS REMOVED AND NO DEFECTS WERE OBSERVED. THE SHEATH REMOVER WHEN INSTALLED ON THE DEVICE WILL PREVENT THE SHEATH AND FIRING ASSEMBLY FROM MOVING INWARDS INTO THE DEVICE TO TRIGGER THE FIRING MECHANISM, AS THERE IS NOT ENOUGH CLEARANCE FOR THE SHEATH TO MOVE INWARDS WHEN THE SHEATH IS INSTALLED. IF THE SHEATH REMOVER IS REMOVED AND THE SHEATH REMAIN THE DEVICE WILL TRIGGER AND FIRE IF BOTH BLUE CAPS ARE REMOVED. THE SHEATH REMOVER AND SHEATH WERE INSPECTED TO ENSURE THERE WERE NO VISIBLE DEFECTS AND THE SHEATH REMOVER WAS PROPERLY SEATED OVER THE SHEATH. THERE WERE NO DEFECTS OBSERVED. THE SHEATH REMOVER WAS GRASPED WITH FOREFINGER AND THUMB, THEN PULLED AWAY FROM THE DEVICE PER THE IFU. THE SHEATH REMOVER REMOVED THE SHEATH WITH MINIMAL FORCE. AS THERE WAS MINIMAL FORCE TO REMOVE THE SHEATH, IT IS UNKNOWN WHY THE USER WAS NOT ABLE TO REMOVE THE SHEATH USING THE SHEATH REMOVER IN THE FIELD AS THERE WERE NO DEFECTS OBSERVED. THE NEEDLE WAS EXAMINED UNDER MAGNIFICATION AND NO SKIN TISSUE OR RED RESIDUE WAS OBSERVED ON THE NEEDLE; LACK OF RESIDUE IS EVIDENCE THAT THE AUTO-INJECTOR HAD NOT BEEN ADMINISTERED TO A PATIENT. THE NEEDLE WAS PROJECTING FROM THE RED NOSE CAP AT 0.5160" (MET SPECIFICATION 0.4-0.6"). THE SHEATH REMOVER PETALS WERE MEASURED, AND ALL EIGHT (8) PETALS MEASURED AT A 0.0195", ALL PETALS MET SPECIFICATION OF 0.018" +/- 0.003". THE INSIDE OF THE SHEATH REMOVER WAS INSPECTED TO IDENTIFY THE MOLD CAVITY, THE PART WAS FROM CAVITY 14. THE FIRING MECHANISM WAS INSPECTED, AND NO DEFECT WAS OBSERVED. THE SPRING RELEASE TINES WERE NOT IN CONTACT WITH THE FIRING BUSHING, IN ADDITION THE ADJUSTMENT SCREW WAS AGAINST THE STOP COLLAR, EVIDENCE THE DEVICE HAD BEEN FIRED AND DELIVERED A DOSE. THE SAMPLE WAS INSPECTED, AND NO DEFECTS WERE OBSERVED. ALL INTERNAL COMPONENTS WERE PRESENT. BASED ON THE COMPLAINT SAMPLE EVALUATION OF THE REPORTED COMPLAINT "NEEDLE DID NOT COME OUT OF FIRST PEN" WAS CONFIRMED AS THE SHEATH REMAINED ON THE DEVICE. HOWEVER, DURING FUNCTIONAL TESTING, THE SHEATH REMOVER WAS CAPABLE OF REMOVING THE SHEATH AND IS NOT CONSIDERED A MALFUNCTION SINCE IT WAS ABLE TO BE REMOVED PER THE IFU INSTRUCTIONS. IT IS UNKNOWN HOW THE CONSUMER REMOVED THE SHEATH REMOVER, BUT SINCE THE FUNCTIONAL TESTING CONFIRMED THE SHEATH WAS CAPABLE OF BEING REMOVED EASILY, THE ROOT CAUSE ASSIGNED IS POTENTIAL USER ERROR (NOT FOLLOWING INSTRUCTIONS PER THE IFU) AS THERE WERE NO DEFECTS OBSERVED. THE IFU WAS REVIEWED. PER THE IFU ¿PULL OFF BOTH BLUE CAPS. YOU WILL NOW SEE THE RED TIP.¿ THERE IS AN ILLUSTRATION SHOWING THE PEN WITH THE SHEATH REMOVER AND SHEATH REMOVED, ONLY THE RED TIP IS VISIBLE. FOR THE SHEATH REMOVER THERE IS AN IMAGE OF THE SHEATH REMOVER WITH SHEATH. AS THERE ARE ADEQUATE INSTRUCTIONS FOR PREPARING THE DEVICE AND THE COMPLAINT SAMPLE CONFIRMED THE SHEATH REMOVER WAS CAPABLE OF REMOVING THE SHEATH, THE IFU WAS NOT CAUSAL OF THE REPORTED COMPLAINT. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG, LOT G230603X FOR THE COMPLAINT CATEGORY ¿ ¿SHEATH NOT REMOVED BY THE SHEATH REMOVER¿, FOR THE REPORTED COMPLAINT DETERMINED THE MANUFACTURING, ASSEMBLY OR PACKAGING DID NOT CONTRIBUTE TO THE REPORTED COMPLAINT. ALL IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR THE LOT MANUFACTURED AT PHILLIPS-MEDISIZE. A RETAIN REVIEW WAS PERFORMED AND THE PRODUCT CONFORMED WHEN FUNCTIONALLY TESTED. THE COMPLAINT SAMPLE WAS INSPECTED, AND THE REPORTED COMPLAINT WAS NOT SUBSTANTIATED. THE REPORTED COMPLAINT ASSIGNED IS POTENTIAL USER ERROR FOR NOT FOLLOWING THE IFU TO REMOVE THE BLUE CAPS. THERE WERE NO MALFUNCTIONS OBSERVED DURING THE COMPLAINT SAMPLE INSPECTION OR FUNCTIONAL TESTING OF THE SAMPLES. 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1798132 | TWINJECT/ADRENACLICK | TYPE 2 | PQX | PHILLIPS-MEDISIZE LLC | G230603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female | Other |