BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINJECT/ADRENACLICK

    MDR report key: 20181175 · Received September 10, 2024

    Report

    Report Number
    3002919960-2024-00035
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Report Date
    September 19, 2024
    Product Code
    PQX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS NOTED THE NEEDLE BENT [NEEDLE ISSUE] DID NOT ADMINISTER THE DRUG [DRUG DOSE OMISSION BY DEVICE] ADMINISTRATION THROUGH THE CLOTHES [WRONG TECHNIQUE IN DEVICE USAGE PROCESS] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL REGULATORY REPORT CONCERNS ADVERSE EVENTS OF NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND NO ADVERSE EVENT IN A PATIENT (GENDER, AGE AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 03-SEP-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER VIA AN EMAIL FROM REGULATORY AUTHORITY US FOOD AND DRUG ADMINISTRATION, WITH REFERENCE NUMBER (B)(4) CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: 0115-1694-30, LOT, AND EXPIRATION DATE WERE NOT REPORTED) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ANAPHYLACTIC SHOCK. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC SHOCK. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT TRIED TO USE GENERIC EPINEPHRINE PEN. UPON ADMINISTRATION THROUGH THE CLOTHES, IT WAS NOTED THE NEEDLE BENT AND DID NOT ADMINISTER THE DRUG. THE SECOND DOSE/DEVICE WAS REQUESTED TO TREAT ANAPHYLACTIC SHOCK. FURTHER REPORTER CONFIRMED THAT THE PATIENT WAS GIVEN WITH SECOND EPI PEN WHICH WORKED FINE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Description of Event or Problem · 0

    DID NOT ADMINISTER THE DRUG [DRUG DOSE OMISSION BY DEVICE]. IT WAS NOTED THE NEEDLE BENT [NEEDLE ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL REGULATORY REPORT CONCERNS ADVERSE EVENTS OF NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND NO ADVERSE EVENT IN A PATIENT (GENDER, 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) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER VIA AN EMAIL FROM REGULATORY AUTHORITY US FOOD AND DRUG ADMINISTRATION, WITH REFERENCE NUMBER (B)(4) CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS BEING TREATED WITH TWINJECT (EPINEPHRINE AUTO-INJECTOR) 0.3 MILLIGRAM (NDC: 0115-1694-30, LOT, AND EXPIRATION DATE WERE NOT REPORTED) (DOSE, FREQUENCY, ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR ANAPHYLACTIC SHOCK. CONCURRENT CONDITIONS INCLUDED ANAPHYLACTIC SHOCK. CONCOMITANT MEDICATIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES/SURGERIES, HISTORY OF ALLERGIES, HISTORY OF SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE WAS NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT TRIED TO USE GENERIC EPINEPHRINE PEN. UPON ADMINISTRATION THROUGH THE CLOTHES, IT WAS NOTED THE NEEDLE BENT AND DID NOT ADMINISTER THE DRUG. THE SECOND DOSE/DEVICE WAS REQUESTED TO TREAT ANAPHYLACTIC SHOCK. FURTHER REPORTER CONFIRMED THAT THE PATIENT WAS GIVEN WITH SECOND EPI PEN WHICH WORKED FINE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS 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 17-SEP-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT. ON 03-SEP-2024, AMNEAL PRODUCT COMPLAINTS RECEIVED A PRODUCT COMPLAINT NOTIFICATION FOR EPINEPHRINE AUTO-INJECTOR 0.3 MG, LOT UNKNOWN, NEEDLE BENT AND DID NOT ADMINISTER THE DRUG. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR DEFECTIVE INJECTOR AND BENT NEEDLE. THE CMO PFIZER INVESTIGATION WAS NOT WARRANTED AS THE COMPLAINT WAS RELATED TO THE ASSEMBLY AND PACKAGING OF THE DEVICE AT PHILLIPS. AN INVESTIGATION WAS PERFORMED BY PHILLIPS FOR 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. THE CONTROLLED ANNUAL PRODUCT REPORTS FROM MAY 30, 2021, TO MAY 29, 2023, WERE REVIEWED FOR DEVIATIONS/INVESTIGATIONS THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT. THERE WERE NO DEVIATIONS/DISCREPANCIES FOUND THAT MAY HAVE LED TO THE DEFECT REPORTED BY THE CUSTOMER. ALL IN-PROCESS AND FINAL RELEASE CRITERIA WERE MET FOR ALL LOTS MANUFACTURED AT PHILLIPS-MEDISIZE. THERE HAVE BEEN 12 OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY BENT NEEDLE IN THE PAST 24 MONTHS. NONE OF THE 12 SIMILAR COMPLAINTS WERE ATTRIBUTABLE TO THE MANUFACTURING PROCESS. THERE HAVE BEEN 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. A REVIEW OF THE PFMEA WAS COMPLETED TO CONFIRM IF THE FAILURE MODES ARE CAPTURED WITHIN THE CURRENT ASSEMBLY PROCESS. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION AS SUCH COULD NOT BE CONFIRMED. CONTROLS ARE IN-PLACE TO ASSURE NEEDLES DO NOT EXCEED AN ANGLE OF 2 DEGREES FROM STRAIGHT. THE DEVICE IS DESIGNED SUCH THAT THE NEEDLE REMAINS UNEXPOSED (WITHIN THE NOSE CAP) UNTIL AFTER ADMINISTRATION OF THE DOSE. POST-ADMINISTRATION, THE NEEDLE PROTRUDES FROM THE RED NOSE CAP WHEN REMOVED FROM THE PATIENT¿S THIGH. IF NOT REMOVED FROM THE THIGH PROPERLY (PULLED STRAIGHT OUT), THEN THERE IS A POTENTIAL FOR THE NEEDLE TO BEND. THE APPROVED INSTRUCTIONS FOR USE STATE, ¿PLACE THE RED TIP AGAINST THE MIDDLE OF THE OUTER THIGH (UPPER LEG) AT A 90-DEGREE ANGLE (PERPENDICULAR) TO THE THIGH. PRESS DOWN HARD AND HOLD FIRMLY AGAINST THE THIGH FOR APPROXIMATELY 10 SECONDS TO DELIVER THE MEDICINE. ONLY INJECT INTO THE MIDDLE OF OUTER THIGH. DO NOT INJECT INTO ANY OTHER PART OF THE BODY. REMOVE EPINEPHRINE INJECTION FROM THE THIGH. EPINEPHRINE INJECTION SHOULD ONLY BE INJECTED INTO THE MIDDLE OF THE OUTER THIGH (UPPER LEG). IT CAN BE INJECTED THROUGH CLOTHING IF NEEDED. AS PART OF POST MARKETING REQUIREMENTS (PMR-3479-1), A TOTAL OF 325 DEVICES WERE TESTED DURING DOSE RELIABILITY TESTING FOR PMR 3479-01. TESTING ALSO INCLUDED FIRING DEVICES INTO DENIM. BENT NEEDLES WERE NOT SEEN WHEN THE INSERTION AND REMOVAL ANGLES WERE KEPT THE SAME. NEEDLE ANGLES WERE PRIMARILY INFLUENCED BY ROTATION OF AN ACTIVATED DEVICE PRIOR TO REMOVAL. THIS FINDING INDICATES THAT THE MOST LIKELY CAUSAL FACTOR FOR REPORTED BENT NEEDLE COMPLAINTS IS NOT ATTRIBUTED TO THE MANUFACTURING PROCESS BUT RATHER DUE TO THE HANDLING BY END USERS. ADEQUATE CONTROLS ARE IN PLACE TO PREVENT THE POTENTIAL OF BENT NEEDLE DEFECTS BEING GENERATED AND GOING UNDETECTED IN THE MANUFACTURING PROCESS. AS THERE WAS A LACK OF DETAILS FOR THE REPORTED COMPLAINT AND THE COMPLAINT SAMPLE WAS NOT RETURNED A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG, LOT UNKNOWN FOR THE COMPLAINT CATEGORY ¿DEFECTIVE INJECTOR; BENT NEEDLE, CONFIRMED ALL AUTOINJECTORS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND MET SPECIFICATION FOR RELEASE. THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVALUATION, AS SUCH THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON PRIOR STUDIES, BENT NEEDLE COMPLAINTS ARE NOT ATTRIBUTED TO THE MANUFACTURING PROCESS BUT RATHER DUE TO THE HANDLING BY END USERS. ADEQUATE CONTROLS ARE IN PLACE TO PREVENT THE POTENTIAL OF BENT NEEDLE DEFECTS BEING GENERATED AND GOING UNDETECTED IN THE MANUFACTURING PROCESS. AS THERE WAS A LACK OF DETAILS FOR THE REPORTED COMPLAINT AND THE COMPLAINT SAMPLE WAS NOT RETURNED A ROOT CAUSE RELATED TO USER ERROR COULD NOT BE DETERMINED. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING OR ASSEMBLY PROCESS THAT WERE DETERMINED TO BE ATTRIBUTED TO THE REPORTED COMPLAINT. ALL AUTO-INJECTORS RELEASED TO MARKET WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS AND MET SPECIFICATIONS FOR RELEASE. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS, AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS, AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE ISSUE, DRUG DOSE OMISSION BY DEVICE, WRONG TECHNIQUE IN DEVICE USAGE PROCESS, AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. 0N 19-SEP-2024, CORRECTION WAS DONE AS EVENT (WRONG TECHNIQUE IN DEVICE USAGE PROCESS) WAS DELETED AND EVENT (DRUG DOSE OMISSION BY DEVICE) REPLACED AS PRIMARY EVENT. LISTEDNESS CRITERIA WAS CHANGED FROM UNLISTED TO LISTED FOR EVENT (NEEDLE ISSUE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2330264 TWINJECT/ADRENACLICK TYPE 2 PQX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other