BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FYLNETRA (PEGFILGRASTIM-PBBK) INJECTION

    MDR report key: 20469114 · Received October 17, 2024

    Report

    Report Number
    3011289655-2024-00008
    Event Type
    Malfunction
    Date Received
    October 17, 2024
    Report Date
    December 9, 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

    Description of Event or Problem · 0

    NEEDLE WAS BENT [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 10-OCT-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER REPORTER VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). THE PATIENT WAS BEING TREATED WITH FYLNETRA (PEGFILGRASTIM) INJECTION (NDC, LOT, EXP DATE, SERIAL NUMBER, 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 RECEIVED A PRODUCT COMPLAINT AS THE NEEDLE WAS BENT WITHIN PACKAGE AND REQUESTED FOR THE REPLACEMENT. 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 (#1) INFORMATION RECEIVED ON 06-DEC-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. A PRODUCT COMPLAINT WAS RECEIVED VIA EMAIL ON 17-OCT-2024 FROM AMNEAL PHARMACEUTICALS LLC, A MARKETING AUTHORIZATION HOLDER OF KASHIV BIOSCIENCES LLC, CHICAGO. AS THE SPECIFIC LOT NUMBER IS NOT AVAILABLE, IMPACT IS EVALUATED FOR THE FYLNETRA PRODUCT. BASED ON THE HISTORICAL TREND REVIEW, THERE IS NO IMPACT ON THE PRODUCT QUALITY IS ANTICIPATED. THE GLASS SYRINGES USED IN THE BATCH WERE SOURCED FROM AN APPROVED SUPPLIER AND RELEASED AFTER MEETING ALL QUALITY REQUIREMENTS. VISUAL INSPECTIONS BY QUALIFIED PERSONNEL AND ADDITIONAL QUALITY ASSURANCE CHECKS AT VARIOUS POINTS IN THE MANUFACTURING AND PACKAGING PROCESS ENSURED THAT ONLY GOOD PRE-FILLED SYRINGE (PFS) UNITS WERE DISTRIBUTED, MAINTAINING THE QUALITY AND EFFICACY OF THE PRODUCT. AS THERE IS NO DETAIL RELATED TO THE INJECTION STATUS OF THE COMPLAINT SAMPLE AVAILABLE OTHER THAN THE REQUEST FOR REPLACEMENT AS WELL AS NO ADVERSE EVENT IS REPORTED BY THE COMPLAINANT, IT CAN BE INFERRED THAT THERE IS NO IMPACT ON PATIENT SAFETY. IN CONCLUSION, THE INVESTIGATION CONFIRMS THAT EFFECTIVE CONTROLS AND PROCEDURES ARE IN PLACE AT THE SUPPLIER'S FACILITY TO IDENTIFY AND REJECT GLASS SYRINGES WITH BENT NEEDLES. EACH PRE-FILLED SYRINGE (PFS) WAS PROPERLY EQUIPPED WITH A SAFETY DEVICE AND SECURELY PACKAGED TO PREVENT DAMAGE DURING HANDLING AND TRANSIT. TRAINED PERSONNEL CONDUCTED COMPREHENSIVE INSPECTIONS AT EACH STAGE OF PRODUCTION I.E., ASSEMBLY, BLISTERING, AND CARTON PACKING ENSURING THAT ONLY COMPLIANT PRE-FILLED SYRINGE (PFS) UNITS PROCEEDED TO FINAL PACKAGING, THEREBY MINIMIZING THE RISK OF BENT NEEDLES AT KASHIV BIOSCIENCES, LLC, CHICAGO. HOWEVER, DUE TO THE ABSENCE OF LOT INFORMATION OR A PHOTOGRAPH OF THE COMPLAINT SAMPLE, AN ASSESSMENT OF THE SPECIFIC COMPLAINT COULD NOT BE CARRIED OUT, AND THE ROOT CAUSE REMAINS UNDETERMINED. THE INVESTIGATION WILL BE UPDATED UPON RECEIPT OF THE REQUIRED DETAILS. 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.

    Description of Event or Problem · 0

    NEEDLE WAS BENT [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 10-OCT-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM OTHER REPORTER VIA A TELEPHONE CALL CONCERNING ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA (PEGFILGRASTIM-PBBK). THE PATIENT WAS BEING TREATED WITH FYLNETRA (PEGFILGRASTIM) INJECTION (NDC, LOT, EXP DATE, SERIAL NUMBER, 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 RECEIVED A PRODUCT COMPLAINT AS THE NEEDLE WAS BENT WITHIN PACKAGE AND REQUESTED FOR THE REPLACEMENT. 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
    1149423 FYLNETRA (PEGFILGRASTIM-PBBK) INJECTION TYPE 2 PGO KASHIV BIOSCIENCES LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other