FYLNETRA (PEGFILGRASTIM-PBBK) INJECTION
Report
- Report Number
- 3011289655-2024-00004
- Event Type
- Malfunction
- Date Received
- September 10, 2024
- Report Date
- October 25, 2024
- Manufacturer
- KASHIV BIOSCIENCES LLC
- Product Code
- PGO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THEY HAVE 3 FYLNETRA WITH A SLIGHTLY BENT NEEDLE [NEEDLE ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT] . CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF NEEDLE 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 (B)(6) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER REPORTER VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH FYLNETRA (PEGFILGRASTIM) INJECTION (STRENGTH, 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. IT WAS REPORTED THAT THEY HAVE 3 FYLNETRA WITH A SLIGHTLY BENT NEEDLE. FURTHER CONFIRMED THAT THEY ADMINISTERED THE DRUG ANYWAY BUT HAVE BROUGHT IT TO ATTENTION. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. FOLLOW-UP (#1) INFORMATION RECEIVED ON 17-SEP-2024. FOLLOW-UP SIGNIFICANT INFORMATION RECEIVED FROM OTHER REPORTER VIA AN EMAIL. NEW INFORMATION INCLUDED PRODUCT NDC, LOT NUMBER AND EXPIRY DATE WAS ADDED. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH FYLNETRA (PEGFILGRASTIM) INJECTION (STRENGTH, DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) (LOT NO. 50024004, EXPIRY DATE-29-DEC-2025, NDC-70121-1627-1) FOR AN UNKNOWN INDICATION. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE 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 23-OCT-2024. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. A PRODUCT COMPLAINT WAS RECEIVED VIA E-MAIL ON 05-SEP-2024 FROM AMNEAL PHARMACEUTICALS LLC, A MARKETING AUTHORIZATION HOLDER OF KASHIV BIOSCIENCES LLC, CHICAGO. THE INVESTIGATION CONFIRMS THAT EFFECTIVE CONTROLS AND PROCEDURES ARE IN PLACE TO IDENTIFY AND REJECT GLASS SYRINGES WITH BENT NEEDLES AT THE SUPPLIER'S FACILITY. EACH PRE-FILLED SYRINGE (PPS) IS SECURELY EQUIPPED WITH A SAFETY DEVICE AND PROPERLY PLACED INTO THE BLISTER, CARTON, AND SHIPPER TO MINIMIZE DAMAGE RISKS DURING HANDLING AND TRANSIT. TRAINED PERSONNEL CONDUCT THOROUGH INSPECTIONS AT EACH STAGE-ASSEMBLY, BLISTERING, AND CARTON PACKING-FOR LOT NO. 50024004, ENSURING THAT ONLY COMPLIANT PFS UNITS PROCEED TO FINAL PACKAGING, SIGNIFICANTLY REDUCING THE LIKELIHOOD OF BENT NEEDLES AT KASHIV BIOSCIENCES, LLC, CHICAGO. ANALYSIS OF THE COMPLAINT SAMPLE PHOTOGRAPH AND BLISTER POCKET DIMENSIONS INDICATES THAT A PFS WITH A SLIGHTLY BENT NEEDLE SHIELD COULD FIT INTO THE BLISTER PACK DURING THE BLISTERING STAGE. HOWEVER, THE NEEDLE IS SLIGHTLY BENT, SUGGESTING THAT THE PFS MAY NOT HAVE BEEN DETECTED DURING THE BLISTER INSPECTION STAGE. ADDITIONALLY, INADVERTENT HANDLING ERRORS DURING THE REMOVAL OF THE NEEDLE SHIELD FROM THE PFS OR THE EXTRACTION OF THE PFS FROM THE BLISTER AT THE USER END CANNOT BE RULED OUT. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE 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.
THEY HAVE 3 FYLNETRA WITH A SLIGHTLY BENT NEEDLE [NEEDLE ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF NEEDLE 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 (B)(6)2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER REPORTER VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH FYLNETRA (PEGFILGRASTIM) INJECTION (STRENGTH, 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. IT WAS REPORTED THAT THEY HAVE 3 FYLNETRA WITH A SLIGHTLY BENT NEEDLE. FURTHER CONFIRMED THAT THEY ADMINISTERED THE DRUG ANYWAY BUT HAVE BROUGHT IT TO ATTENTION. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. FOLLOW-UP (#1) INFORMATION RECEIVED ON 17-SEP-2024. FOLLOW-UP SIGNIFICANT INFORMATION RECEIVED FROM OTHER REPORTER VIA AN EMAIL. NEW INFORMATION INCLUDED PRODUCT NDC, LOT NUMBER AND EXPIRY DATE WAS ADDED. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH FYLNETRA (PEGFILGRASTIM) INJECTION (STRENGTH, DOSE, FREQUENCY AND THERAPY DATES WERE NOT REPORTED) (LOT NO. 50024004, EXPIRY DATE-29-DEC-2025, NDC-70121-1627-1) FOR AN UNKNOWN INDICATION. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
THEY HAVE 3 FYLNETRA WITH A SLIGHTLY BENT NEEDLE [NEEDLE ISSUE]. NO ADVERSE EVENT. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF NEEDLE 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 28-AUG-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER REPORTER VIA AN EMAIL CONCERNING ABOVE-MENTIONED EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH FYLNETRA (PEGFILGRASTIM) INJECTION (STRENGTH, 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. IT WAS REPORTED THAT THEY HAVE 3 FYLNETRA WITH A SLIGHTLY BENT NEEDLE. FURTHER CONFIRMED THAT THEY ADMINISTERED THE DRUG ANYWAY BUT HAVE BROUGHT IT TO ATTENTION. LAST ACTION TAKEN WITH FYLNETRA IN RELATION TO NEEDLE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF NEEDLE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER DID NOT PROVIDE THE CAUSALITY OF NEEDLE ISSUE AND NO ADVERSE EVENT WITH FYLNETRA. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2296232 | FYLNETRA (PEGFILGRASTIM-PBBK) INJECTION | TYPE 2 | PGO | KASHIV BIOSCIENCES LLC | 50024004 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |