BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TWINJECT/ADRENACLICK

    MDR report key: 20192425 · Received September 11, 2024

    Report

    Report Number
    3002919960-2024-00036
    Event Type
    Malfunction
    Date Received
    September 11, 2024
    Report Date
    September 30, 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

    INJECTOR JAMMED [DEVICE MECHANICAL ISSUE] NEEDLE DOES NOT RETRACT AFTER THE DOSE IS ADMINISTERED [DEVICE DEPLOYMENT ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL REGULATORY REPORT CONCERNS OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WAS 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 NURSE VIA AN EMAIL FROM REGULATORY AUTHORITY US FOOD AND DRUG ADMINISTRATION, WITH REFERENCE NUMBER (AER: (B)(4)) CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS USING TWINJECT 0.3 MG (EPINEPHRINE INJECTION, AUTO-INJECTOR) (BATCH/LOT: G240201X AND EXPIRATION DATE: 31-JUL-2025, (B)(4)) (ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CURRENT CONDITION, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CONCURRENT CONDITION, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6)2024. PATIENT REQUIRED EPINEPHRINE INJECTIONS AND THE 0.3MG AUTO-INJECTORS WERE RETRIEVED FROM THE PYXIS STATION. THE AUTO-INJECTORS WERE NOT ABLE TO BE USED EFFECTIVELY TO TREAT THE PATIENT'S CONDITION. THE NURSE STATED THE FOLLOWING MORNING THAT THE INJECTOR JAMMED, AND THEY THEN HAD TO USE A VIAL OF EPINEPHRINE TO ADMINISTER A DOSE TO THE PATIENT. THE BOX WAS BROUGHT TO THE PHARMACY. MANUFACTURER AMNEAL. THE MEDICATION SAFETY PHARMACIST TESTED AN AUTO-INJECTOR USING A STRESS BALL. THE DEVICE WORKED PROPERLY HOWEVER IT WAS NOTED THAT THE NEEDLE DOES NOT RETRACT AFTER THE DOSE WAS ADMINISTERED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE 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 19-SEP-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 G2402021X, ¿INJECTOR JAMMED¿. THE INVESTIGATION COMPLAINT SUB-TYPE BASED ON THE COMPLAINT INFORMATION WAS DETERMINED TO BE FOR ¿FAILURE TO FIRE¿. 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 NOT SEE A CORRELATION BETWEEN TECHNICAL COMPLAINT (B)(4) AND THE MANUFACTURING PROCESS AT PMM. THE RESERVE SAMPLE FIRED 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. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED FOR LOT G240201X FOR THE PAST 24 MONTHS. THERE HAVE BEEN (B)(4) OTHER, SIMILAR COMPLAINTS REPORTED IN THE COMPLAINT CATEGORY ¿FAILURE TO FIRE¿ IN THE PAST 24 MONTHS. NONE OF THE (B)(4) SIMILAR COMPLAINTS WERE ATTRIBUTED TO THE MANUFACTURING PROCESS. RETAIN REVIEW CONFORMED, SAMPLE TESTED FIRE PROPERLY AND DELIVERED A DOSE. BASED ON THE RETAIN REVIEW 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; HENCE THE COMPLAINT COULD NOT BE CONFIRMED. REVIEW OF THE INSTRUCTIONS FOR USE WAS PERFORMED, ¿PULL OFF BOTH BLUE CAPS. 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. THE INSTRUCTIONS FOR USE (IFU) CLEARLY DETAIL THE STEPS FOR ADMINISTRATION OF THE DEVICE. AS PER THE INTAKE INFORMATION, ¿THE AUTO-INJECTORS WERE NOT ABLE TO BE USED EFFECTIVELY TO TREAT THE PATIENT'S CONDITION. THE NURSE STATED THE FOLLOWING MORNING THAT THE INJECTOR "JAMMED AND THEY THEN HAD TO USE A VIAL OF EPINEPHRINE TO ADMINISTER A DOSE TO THE PATIENT. THE BOX WAS BROUGHT TO THE PHARMACY. THE MEDICATION SAFETY PHARMACIST TESTED AN AUTO-INJECTOR USING A STRESS BALL. THE DEVICE WORKED PROPERLY, HOWEVER IT WAS NOTED THAT THE NEEDLE DOES NOT RETRACT AFTER THE DOSE IS ADMINISTERED." BASED ON THE FACT IT WAS REPORTED THAT THE DEVICE WORKED PROPERLY, A POTENTIAL ROOT CAUSE FOR THE REPORTED COMPLAINT IS USER ERROR FOR FAILURE TO FOLLOW INSTRUCTIONS FOR USE. TO ADDRESS THE REPORTED NEEDLE DOES NOT RETRACT, THE AMNEAL DEVICE IS NOT DESIGNED FOR NEEDLE RETRACTION. AFTER ADMINISTRATION THE NEEDLE STICKS OUT OF THE DEVICE. THE IFU HAS INSTRUCTIONS FOR POST-ADMINISTRATION USE AND STORAGE. THE INVESTIGATION ASSOCIATED WITH EPINEPHRINE INJECTION USP AUTO-INJECTOR 0.3 MG; LOT G240201X FOR THE COMPLAINT CATEGORY-FAILURE TO FIRE, FOR THE REPORTED COMPLAINT ¿INJECTOR JAMMED¿ CONFIRMED THAT THE AUTO-INJECTORS WERE MANUFACTURED IN ACCORDANCE WITH APPROVED BATCH RECORDS. THE EVALUATION OF THE RETAIN SAMPLE CONFORMED AND MET SPECIFICATION. THE COMPLAINT SAMPLE EVALUATION WAS NOT RETURNED FOR EVALUATION; HENCE THE COMPLAINT WAS NOT CONFIRMED. BASED ON THE FACT IT WAS REPORTED THAT THE DEVICE WORKED PROPERLY, A POTENTIAL ROOT CAUSE FOR THE REPORTED COMPLAINT IS USER ERROR FOR FAILURE TO FOLLOW INSTRUCTIONS FOR USE. THERE WERE NO ISSUES RELATED TO THE MANUFACTURING PROCESS THAT WERE DETERMINED TO BE ATTRIBUTED TO THE 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 TWINJECT IN RELATION TO DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE 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.

    Description of Event or Problem · 0

    INJECTOR JAMMED [DEVICE MECHANICAL ISSUE]. NEEDLE DOES NOT RETRACT AFTER THE DOSE IS ADMINISTERED [DEVICE DEPLOYMENT ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL REGULATORY REPORT CONCERNS OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WAS 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 NURSE VIA AN EMAIL FROM REGULATORY AUTHORITY US FOOD AND DRUG ADMINISTRATION, WITH REFERENCE NUMBER (AER: (B)(4)) CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S TWINJECT (EPINEPHRINE AUTO-INJECTOR). THE PATIENT WAS USING TWINJECT 0.3 MG (EPINEPHRINE INJECTION, AUTO-INJECTOR) (BATCH/LOT: G240201X AND EXPIRATION DATE: 31-JUL-2025, (B)(4)) (ROUTE, AND THERAPY DATES WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. CURRENT CONDITION, CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CONCURRENT CONDITION, HISTORY OF PROCEDURES/ SURGERIES, HISTORY OF SMOKING, ALCOHOL CONSUMPTION, AND RECREATIONAL DRUG USE WERE NOT REPORTED. LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT PATIENT PRESENTED TO EMERGENCY DEPARTMENT ON (B)(6) 2024. PATIENT REQUIRED EPINEPHRINE INJECTIONS AND THE 0.3MG AUTO-INJECTORS WERE RETRIEVED FROM THE PYXIS STATION. THE AUTO-INJECTORS WERE NOT ABLE TO BE USED EFFECTIVELY TO TREAT THE PATIENT'S CONDITION. THE NURSE STATED THE FOLLOWING MORNING THAT THE INJECTOR JAMMED, AND THEY THEN HAD TO USE A VIAL OF EPINEPHRINE TO ADMINISTER A DOSE TO THE PATIENT. THE BOX WAS BROUGHT TO THE PHARMACY. MANUFACTURER AMNEAL. THE MEDICATION SAFETY PHARMACIST TESTED AN AUTO-INJECTOR USING A STRESS BALL. THE DEVICE WORKED PROPERLY HOWEVER IT WAS NOTED THAT THE NEEDLE DOES NOT RETRACT AFTER THE DOSE WAS ADMINISTERED. LAST ACTION TAKEN WITH TWINJECT IN RELATION TO DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE MECHANICAL ISSUE, DEVICE DEPLOYMENT ISSUE AND NO ADVERSE EVENT WITH TWINJECT. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592126 TWINJECT/ADRENACLICK TYPE 2 PQX G240201X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other