FYLNETRA (PEGFILGRASTIM-PBBK) INJECTION
Report
- Report Number
- 3011289655-2025-00003
- Event Type
- Malfunction
- Date Received
- June 3, 2025
- Report Date
- September 26, 2025
- Manufacturer
- KASHIV BIOSCIENCES LLC
- Product Code
- PGO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
0.
THE NEEDLE CAME OUT FROM THE SAFETY CLIP/SYRINGE DID DISLODGE DURING ADMINISTRATION [DEVICE ISSUE] , NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 29-APR-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACY TECHNICIAN VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). ADDITIONAL NON-SIGNIFICANT INFORMATION (#1) WAS RECEIVED FROM PHARMACY TECHNICIAN VIA AN EMAIL ON 06-MAY-2025. ADDITIONAL INFORMATION INCLUDED EVENT DETAILS UPDATED IN NARRATIVE. THE PATIENT WAS BEING TREATED WITH FYLNETRA (PEGFILGRASTIM) INJECTION 6/0.6 MG/ML (NDC-70121-1627-1, LOT NO. 50024009, EXPIRY DATE 23-APR-2026, SERIAL NUMBER: (B)(6)), (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) 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. PHARMACY TECHNICIAN REPORTED THAT ON (B)(6) 2025 FYLNETRA- PEGFILGRASTIM INJECTION WAS PURCHASED. ON (B)(6) 2025 WHILE ADMINISTERING THE MEDICATION TO THE PATIENT, IT WAS NOTICED THAT THE NEEDLE CAME OUT OF SAFETY CLIP. LATER IT WAS CONFIRMED THAT PATIENT WAS ADMINISTERED WITH ANOTHER DOSE. FURTHER IT WAS REPORTED THAT DURING ADMINISTRATION, THE SYRINGE DISLODGED FROM THE SAFETY DEVICE. THE OUTER PACKAGING WAS INTACT WITH NO SIGNS OF DAMAGE OR TAMPERING. THE BLISTER PACK CONTAINING THE SYRINGE WAS UNDAMAGED, AND NO DEFORMITIES, CRACKS, OR LOOSENESS WERE OBSERVED IN THE SAFETY GUARD BEFORE OR AFTER USE. THE FACILITY HAD RECEIVED HUNDREDS OF THESE UNITS, AND THIS WAS THE ONLY OCCURRENCE TO DATE. THE SYRINGE WAS NOT HANDLED OR STORED IN ANY UNUSUAL MANNER, NOR WAS ANY PRESSURE ACCIDENTALLY APPLIED TO THE NEEDLE END OF THE SAFETY DEVICE THAT COULD HAVE CAUSED THE DISLODGEMENT. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
THE NEEDLE CAME OUT FROM THE SAFETY CLIP/SYRINGE DID DISLODGE DURING ADMINISTRATION/TWO MORE (B)(6) 6MGMG/0.6ML INJECTIONS WHERE WE HAVE ENCOUNTERED THE SAME ISSUE AGAIN [DEVICE ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 29-APR-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACY TECHNICIAN VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). ADDITIONAL NON-SIGNIFICANT INFORMATION (#1) WAS RECEIVED FROM PHARMACY TECHNICIAN VIA AN EMAIL ON 06-MAY-2025. ADDITIONAL INFORMATION INCLUDED EVENT DETAILS UPDATED IN NARRATIVE. THE PATIENT WAS BEING TREATED WITH (B)(6) INJECTION 6/0.6 MG/ML (NDC-70121-1627-1, LOT NO. 50024009, EXPIRY DATE 23-APR-2026, SERIAL NUMBER: (B)(6), (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) 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. PHARMACY TECHNICIAN REPORTED THAT ON (B)(6) INJECTION WAS PURCHASED. ON (B)(6) 2025 WHILE ADMINISTERING THE MEDICATION TO THE PATIENT, IT WAS NOTICED THAT THE NEEDLE CAME OUT OF SAFETY CLIP. LATER IT WAS CONFIRMED THAT PATIENT WAS ADMINISTERED WITH ANOTHER DOSE. FURTHER IT WAS REPORTED THAT DURING ADMINISTRATION, THE SYRINGE DISLODGED FROM THE SAFETY DEVICE. THE OUTER PACKAGING WAS INTACT WITH NO SIGNS OF DAMAGE OR TAMPERING. THE BLISTER PACK CONTAINING THE SYRINGE WAS UNDAMAGED, AND NO DEFORMITIES, CRACKS, OR LOOSENESS WERE OBSERVED IN THE SAFETY GUARD BEFORE OR AFTER USE. THE FACILITY HAD RECEIVED HUNDREDS OF THESE UNITS, AND THIS WAS THE ONLY OCCURRENCE TO DATE. THE SYRINGE WAS NOT HANDLED OR STORED IN ANY UNUSUAL MANNER, NOR WAS ANY PRESSURE ACCIDENTALLY APPLIED TO THE NEEDLE END OF THE SAFETY DEVICE THAT COULD HAVE CAUSED THE DISLODGEMENT. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 21-JUN-2025. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. IN CONCLUSION, THE INVESTIGATION CONFIRMS THAT ROBUST CONTROLS AND PROCEDURES ARE IN PLACE TO IDENTIFY AND REJECT ANY ABNORMALITIES OBSERVED DURING PACKAGING OF LOT NO. 50024009. TRAINED PERSONNEL CONDUCTED INSPECTIONS AFTER ASSEMBLY AND PACKAGING, FINDING NO INSTANCES OF DAMAGE, WHICH INDICATES A REMOTE POSSIBILITY OF TRANSCENDING PPS WITH DAMAGED SAFETY DEVICES FROM (B)(6) CHICAGO. WHILE THIS MARKET COMPLAINT IS THE FIRST OF ITS KIND FOR FYLNETRA, EFFECTIVE CONTROLS, INCLUDING 100% INSPECTION OF MEDICATION UNITS, INDICATES THAT THE INCIDENT IS ISOLATED. OUT OF THE (B)(4) PREFILLED SYRINGE (PPS) UNITS DISTRIBUTED FROM LOT NO. 50024009, ONLY ONE (1) COMPLAINT HAS BEEN RECEIVED RELATED TO THE SAFETY DEVICE. ALL QUALITY CONTROL CHECKS CONFIRMED THAT THE PRODUCT MET ITS INTENDED QUALITY ATTRIBUTES AND EFFICACY REQUIREMENTS. AWARENESS TRAINING HAS BEEN PROVIDED TO PERSONNEL TO ENHANCE VIGILANCE DURING VISUAL INSPECTIONS. NO ADVERSE EFFECTS ON PATIENT SAFETY HAVE BEEN REPORTED; HOWEVER, FUTURE USE OF ANY BROKEN OR DAMAGED PFS SHOULD BE AVOIDED, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. 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. FOLLOW UP (#3) INFORMATION WAS RECEIVED ON 07-JUL-2025. SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED FROM PHARMACY TECHNICIAN VIA AN EMAIL. NEW INFORMATION INCLUDED TWO MORE INCIDENCE WITH SAME DEVICE ISSUE AND DOSAGE REGIMEN WAS ADDED. ON AN UNKNOWN DATE, THE PATIENT WAS BEING TREATED WITH (B)(6) INJECTION 6/0.6 MG/ML (LOT NO., EXPIRY DATE, AND SERIAL NUMBER WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. THE PHARMACY TECHNICIAN REPORTED THAT, TWO MORE (B)(6) 6MG/0.6ML INJECTIONS WHERE THEY HAD ENCOUNTERED THE SAME ISSUE AGAIN. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#4) INFORMATION WAS RECEIVED ON 23-SEP-2025. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT ATTACHED TO THIS CASE. THE INVESTIGATION CONFIRMS THAT ROBUST CONTROLS AND PROCEDURES ARE IN PLACE TO IDENTIFY AND REJECT ANY ABNORMALITIES OBSERVED DURING PACKAGING OF LOT NO. 50024009. TRAINED PERSONNEL CONDUCTED INSPECTIONS AFTER ASSEMBLY AND PACKAGING, FINDING NO INSTANCES OF DAMAGE, WHICH INDICATES A REMOTE POSSIBILITY OF TRANSFERRING PFS WITH DAMAGED SAFETY DEVICES FROM (B)(6) CHICAGO. THIS IS SECOND MARKET COMPLAINT REPORTED FOR FYLNETRA PRODUCT BY SAME COMPLAINANT AND WAS LIMITED TO A SINGLE BATCH. EFFECTIVE CONTROLS, INCLUDING 100% INSPECTION OF UNITS, WERE IN PLACE, AND ALL QUALITY CONTROL CHECKS CONFIRMED THAT THE PRODUCT MET REQUIRED QUALITY ATTRIBUTES AND EFFICACY STANDARDS. AWARENESS TRAINING WAS CONDUCTED TO IMPROVE VIGILANCE DURING VISUAL INSPECTIONS, REFERENCING THE PREVIOUSLY REPORTED COMPLAINT FROM THE SAME LOT. TO ENHANCE VIGILANCE DURING THE VISUAL INSPECTION OF ASSEMBLED DEVICES, CAPA-25-0020 HAS BEEN INITIATED TO REVISE ALL MBRS RELATED TO SAFETY DEVICE ASSEMBLING, SOP-0585, "ASSEMBLED DEVICE DEFECT CLASSIFICATION AND QUALIFICATION OF INSPECTOR(S)" AND ASSOCIATED TRN-0116 "INTRODUCTION TO ASSEMBLED SYRINGE VISUAL INSPECTION DEFECT PANEL" AND TRN-0117 "ASSEMBLED SYRINGE VISUAL INSPECTION DEFECT PANEL EXAM" TO INCLUDE A VISUAL CHECK OF PROPER PFS FITMENT INTO THE SAFETY DEVICE NOTCH/TABS OF THE ASSEMBLED PFS UNITS DURING INSPECTION. NO ADVERSE EFFECTS ON PATIENT SAFETY HAVE BEEN REPORTED; HOWEVER, USE OF ANY BROKEN OR DAMAGED PFS SHOULD BE AVOIDED, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH (B)(6). 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.
THE NEEDLE CAME OUT FROM THE SAFETY CLIP/SYRINGE DID DISLODGE DURING ADMINISTRATION/TWO MORE FYLNETRA 6MGMG/0.6ML INJECTIONS WHERE WE HAVE ENCOUNTERED THE SAME ISSUE AGAIN [DEVICE ISSUE]. NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 29-APR-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACY TECHNICIAN VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). ADDITIONAL NON-SIGNIFICANT INFORMATION (#1) WAS RECEIVED FROM PHARMACY TECHNICIAN VIA AN EMAIL ON 06-MAY-2025. ADDITIONAL INFORMATION INCLUDED EVENT DETAILS UPDATED IN NARRATIVE. THE PATIENT WAS BEING TREATED WITH FYLNETRA (PEGFILGRASTIM) INJECTION 6/0.6 MG/ML (NDC-70121-1627-1, LOT NO. 50024009, EXPIRY DATE 23-APR-2026, SERIAL NUMBER: (B)(6)), (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) 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. PHARMACY TECHNICIAN REPORTED THAT ON (B)(6) 2025 FYLNETRA- PEGFILGRASTIM INJECTION WAS PURCHASED. ON (B)(6) 2025 WHILE ADMINISTERING THE MEDICATION TO THE PATIENT, IT WAS NOTICED THAT THE NEEDLE CAME OUT OF SAFETY CLIP. LATER IT WAS CONFIRMED THAT PATIENT WAS ADMINISTERED WITH ANOTHER DOSE. FURTHER IT WAS REPORTED THAT DURING ADMINISTRATION, THE SYRINGE DISLODGED FROM THE SAFETY DEVICE. THE OUTER PACKAGING WAS INTACT WITH NO SIGNS OF DAMAGE OR TAMPERING. THE BLISTER PACK CONTAINING THE SYRINGE WAS UNDAMAGED, AND NO DEFORMITIES, CRACKS, OR LOOSENESS WERE OBSERVED IN THE SAFETY GUARD BEFORE OR AFTER USE. THE FACILITY HAD RECEIVED HUNDREDS OF THESE UNITS, AND THIS WAS THE ONLY OCCURRENCE TO DATE. THE SYRINGE WAS NOT HANDLED OR STORED IN ANY UNUSUAL MANNER, NOR WAS ANY PRESSURE ACCIDENTALLY APPLIED TO THE NEEDLE END OF THE SAFETY DEVICE THAT COULD HAVE CAUSED THE DISLODGEMENT. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 21-JUN-2025. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. IN CONCLUSION, THE INVESTIGATION CONFIRMS THAT ROBUST CONTROLS AND PROCEDURES ARE IN PLACE TO IDENTIFY AND REJECT ANY ABNORMALITIES OBSERVED DURING PACKAGING OF LOT NO. 50024009. TRAINED PERSONNEL CONDUCTED INSPECTIONS AFTER ASSEMBLY AND PACKAGING, FINDING NO INSTANCES OF DAMAGE, WHICH INDICATES A REMOTE POSSIBILITY OF TRANSFENING PPS WITH DAMAGED SAFETY DEVICES FROM KASHIV BIOSCIENCES, LLC, CHICAGO. WHILE THIS MARKET COMPLAINT IS THE FIRST OF ITS KIND FOR FYLNETRA, EFFECTIVE CONTROLS, INCLUDING 100% INSPECTION OF MEDICATION UNITS, INDICATES THAT THE INCIDENT IS ISOLATED. OUT OF THE 4,238 PREFILLED SYRINGE (PPS) UNITS DISTRIBUTED FROM LOT NO. 50024009, ONLY ONE (1) COMPLAINT HAS BEEN RECEIVED RELATED TO THE SAFETY DEVICE. ALL QUALITY CONTROL CHECKS CONFIRMED THAT THE PRODUCT MET ITS INTENDED QUALITY ATTRIBUTES AND EFFICACY REQUIREMENTS. AWARENESS TRAINING HAS BEEN PROVIDED TO PERSONNEL TO ENHANCE VIGILANCE DURING VISUAL INSPECTIONS. NO ADVERSE EFFECTS ON PATIENT SAFETY HAVE BEEN REPORTED; HOWEVER, FUTURE USE OF ANY BROKEN OR DAMAGED PFS SHOULD BE AVOIDED, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. 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. FOLLOW UP (#3) INFORMATION WAS RECEIVED ON 07-JUL-2025. SIGNIFICANT FOLLOW-UP INFORMATION WAS RECEIVED FROM PHARMACY TECHNICIAN VIA AN EMAIL. NEW INFORMATION INCLUDED TWO MORE INCIDENCE WITH SAME DEVICE ISSUE AND DOSAGE REGIMEN WAS ADDED. ON AN UNKNOWN DATE, THE PATIENT WAS BEING TREATED WITH FYLNETRA (PEGFILGRASTIM) INJECTION 6/0.6 MG/ML (LOT NO., EXPIRY DATE, AND SERIAL NUMBER WERE NOT REPORTED) FOR AN UNKNOWN INDICATION. THE PHARMACY TECHNICIAN REPORTED THAT, TWO MORE FYLNETRA 6MG/0.6ML INJECTIONS WHERE THEY HAD ENCOUNTERED THE SAME ISSUE AGAIN. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
THE NEEDLE CAME OUT FROM THE SAFETY CLIP/SYRINGE DID DISLODGE DURING ADMINISTRATION [DEVICE ISSUE] , NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE WERE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EVENT EXPERIENCE WAS NOT REPORTED. ON 29-APR-2025, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACY TECHNICIAN VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). ADDITIONAL NON-SIGNIFICANT INFORMATION (#1) WAS RECEIVED FROM PHARMACY TECHNICIAN VIA AN EMAIL ON 06-MAY-2025. ADDITIONAL INFORMATION INCLUDED EVENT DETAILS UPDATED IN NARRATIVE. THE PATIENT WAS BEING TREATED WITH FYLNETRA (PEGFILGRASTIM) INJECTION 6/0.6 MG/ML (NDC-70121-1627-1, LOT NO. 50024009, EXPIRY DATE 23-APR-2026, SERIAL NUMBER: (B)(6), (DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) 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. PHARMACY TECHNICIAN REPORTED THAT ON (B)(6) 2025 FYLNETRA- PEGFILGRASTIM INJECTION WAS PURCHASED. ON (B)(6) 2025 WHILE ADMINISTERING THE MEDICATION TO THE PATIENT, IT WAS NOTICED THAT THE NEEDLE CAME OUT OF SAFETY CLIP. LATER IT WAS CONFIRMED THAT PATIENT WAS ADMINISTERED WITH ANOTHER DOSE. FURTHER IT WAS REPORTED THAT DURING ADMINISTRATION, THE SYRINGE DISLODGED FROM THE SAFETY DEVICE. THE OUTER PACKAGING WAS INTACT WITH NO SIGNS OF DAMAGE OR TAMPERING. THE BLISTER PACK CONTAINING THE SYRINGE WAS UNDAMAGED, AND NO DEFORMITIES, CRACKS, OR LOOSENESS WERE OBSERVED IN THE SAFETY GUARD BEFORE OR AFTER USE. THE FACILITY HAD RECEIVED HUNDREDS OF THESE UNITS, AND THIS WAS THE ONLY OCCURRENCE TO DATE. THE SYRINGE WAS NOT HANDLED OR STORED IN ANY UNUSUAL MANNER, NOR WAS ANY PRESSURE ACCIDENTALLY APPLIED TO THE NEEDLE END OF THE SAFETY DEVICE THAT COULD HAVE CAUSED THE DISLODGEMENT. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 21-JUN-2025. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. IN CONCLUSION, THE INVESTIGATION CONFIRMS THAT ROBUST CONTROLS AND PROCEDURES ARE IN PLACE TO IDENTIFY AND REJECT ANY ABNORMALITIES OBSERVED DURING PACKAGING OF LOT NO. 50024009. TRAINED PERSONNEL CONDUCTED INSPECTIONS AFTER ASSEMBLY AND PACKAGING, FINDING NO INSTANCES OF DAMAGE, WHICH INDICATES A REMOTE POSSIBILITY OF TRANSFENING PPS WITH DAMAGED SAFETY DEVICES FROM KASHIV BIOSCIENCES, LLC, CHICAGO. WHILE THIS MARKET COMPLAINT IS THE FIRST OF ITS KIND FOR FYLNETRA, EFFECTIVE CONTROLS, INCLUDING 100% INSPECTION OF MEDICATION UNITS, INDICATES THAT THE INCIDENT IS ISOLATED. OUT OF THE 4,238 PREFILLED SYRINGE (PPS) UNITS DISTRIBUTED FROM LOT NO. 50024009, ONLY ONE (1) COMPLAINT HAS BEEN RECEIVED RELATED TO THE SAFETY DEVICE. ALL QUALITY CONTROL CHECKS CONFIRMED THAT THE PRODUCT MET ITS INTENDED QUALITY ATTRIBUTES AND EFFICACY REQUIREMENTS. AWARENESS TRAINING HAS BEEN PROVIDED TO PERSONNEL TO ENHANCE VIGILANCE DURING VISUAL INSPECTIONS. NO ADVERSE EFFECTS ON PATIENT SAFETY HAVE BEEN REPORTED; HOWEVER, FUTURE USE OF ANY BROKEN OR DAMAGED PFS SHOULD BE AVOIDED, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO DEVICE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF DEVICE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. 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 |
|---|---|---|---|---|---|---|---|
| 888525 | FYLNETRA (PEGFILGRASTIM-PBBK) INJECTION | TYPE 3 | PGO | KASHIV BIOSCIENCES LLC | 50024009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |