Description of Event or Problem · 0
INJECTION EXPLODES BACK WHILE GIVING TO PATIENT [SYRINGE ISSUE], NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF SYRINGE ISSUE 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-MAY-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM THE OTHER REPORTER VIA A TELEPHONIC CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE. THE PATIENT WAS BEING TREATED WITH MEDROXYPROGESTERONE ACETATE INJECTABLE SUSPENSION/150/MG/ML (NDC: 70121-1480-1, LOT:230173, EXPIRATION DATE: OCT-2025, AND S/E: (B)(6)) FOR AN UNKNOWN INDICATION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CURRENT CONDITIONS, HISTORICAL MEDICATION, MEDICAL HISTORY, HISTORY OF PROCEDURES, ALLERGIES, SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. THE REPORTER STATED THAT ONE OF THE NURSES REPORTED THAT AT HER CLINIC ON (B)(6) 2024 WHILE GIVING THE INJECTION TO THE PATIENT IT EXPLODES BACK FROM THE SYRINGE AND SHE FURTHER REQUESTED FOR THE REPLACEMENT. SHE MENTIONED THAT MEDICATION WAS PURCHASED FROM PHARMACY ON (B)(6) 2024. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE IN RELATION TO SYRINGE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS SYRINGE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SYRINGE ISSUE AND NO ADVERSE EVENT WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE. THIS CASE WAS CONSIDERED AS NON-SERIOUS. THE REPORTABILITY OF THIS CASE WAS PERIODIC. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON 05-JUL-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT. BASED ON THE INVESTIGATION, IT HAS BEEN DETERMINED THAT THE REPORTED DEFECT WITH MEDROXYPROGESTERONE SYRINGES IS UNLIKELY TO HAVE ORIGINATED DURING THE MANUFACTURING PROCESS AT FARMALAN. THE PACKAGING PROCESS CONTROLS WERE PERFORMED WITH CONFORMING RESULTS, AND TESTS PERFORMED WITH ASSEMBLED SYRINGE ALONG WITH NEEDLE MEASURING BREAK LOOSE FORCE AND GLIDING FORCE WERE COMPLIANT. NO RELATED INCIDENTS WERE DETECTED DURING BATCH RECORD REVIEW, AND RETENTION SAMPLES WERE FOUND TO BE COMPLIANT. A GLOBAL REVIEW WITH AMNEAL AND CMO REVEALED THAT THE TRAYS USED FOR HOLDING PRE-FILLED SYRINGES MAY NOT PROVIDE SUFFICIENT SUPPORT, POTENTIALLY LEADING TO DAMAGE DURING TRANSPORTATION. THIS DESIGN ERROR IN THE CURRENT COMMERCIAL PFS HOLDING TRAYS, WHICH HAS NOT UNDERGONE A STRESS STUDY, IS CONSIDERED THE MOST PROBABLE ROOT CAUSE OF THE COMPLAINTS. IN RESPONSE TO THESE FINDINGS, CAPA ACTION FA-CP-2024-042 HAS BEEN INITIATED TO PROPOSE A NEW TRAY DESIGN THAT IMPROVES SECONDARY PACKAGING AND SYRINGE PROTECTION, SUBJECTING IT TO A STRESS STUDY. ADDITIONALLY, DUE TO A CONCERNING TREND OF COMPLAINTS REGARDING MEDROXYPROGESTERONE FOR INJECTION 150MG/ML PFS, A FIELD ALERT REPORT HAS BEEN FILED WITH THE FDA. A QUALITY RISK ASSESSMENT WAS PERFORMED TO EVALUATE ASSOCIATED RISKS RELATED TO PATIENT SAFETY, PRODUCT EFFICACY, AND MARKET COMPLIANCE. AN ADDENDUM TO THIS INVESTIGATION REPORT WAS CONDUCTED TO INCORPORATE THE QUALITY RISK MANAGEMENT (QRM) OUTCOME. BASED ON THE RISK ASSESSMENT, IT WAS OBSERVED THAT THE INCIDENT RATES OF COMPLAINTS ARE VERY LOW. THESE COMPLAINTS ARE ASSESSED AS LOW RISK OVERALL, CONSIDERING THAT ALL DEFECTIVE UNITS WERE IDENTIFIED PRIOR TO USE AND REPLACED WITH NEW UNITS, THUS HAVING NO IMPACT ON PATIENT SAFETY OR PRODUCT EFFICACY. LAST ACTION TAKEN WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE IN RELATION TO SYRINGE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF THE EVENTS SYRINGE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF SYRINGE ISSUE AND NO ADVERSE EVENT WITH MEDROXYPROGESTERONE ACETATE PREFILLED SINGLE-DOSE SYRINGE. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. ON 15-JUL-2024, THIS CASE WAS UPGRADED TO SERIOUS, EXPEDITED FOR MALFUNCTION REPORT SUBMISSION. AMNEAL INITIATED AN INTERNAL INVESTIGATION (NOI REF # (B)(4)) FOR THIS LATE EXPEDITED CASE.