BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FYLNETRA (PEGFILGRASTIM-PBBK)

    MDR report key: 20385150 · Received October 7, 2024

    Report

    Report Number
    3011289655-2024-00006
    Event Type
    Malfunction
    Date Received
    October 7, 2024
    Date of Event
    September 25, 2024
    Report Date
    December 4, 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 ADVERSE EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE 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 PHARMACY TECHNICIAN VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA- PEGFILGRASTIM. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH FYLNETRA- PEGFILGRASTIM 6/0.6 MG/M (NDC: 70121-1627-1, BATCH NO: 50024003, EXP DATE: 07-DEC-2025, S/N: (B)(6)) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CONCOMITANT MEDICATIONS, SMOKER, ALCOHOLIC, ALLERGY, MEDICAL HISTORY, HISTORY OF PROCEDURES, SURGERIES, LABORATORY TESTS AND RECREATIONAL DRUG USE WERE NOT REPORTED. ON UNKNOWN DATE OF SEP-2024, RECEIVED SEALED MEDICATION FROM (B)(6) AND ON (B)(6)2024, WHEN NURSE OPENED THE SYRINGE, SHE OBSERVED THAT THE NEEDLE WAS BENT. LAST ACTION TAKEN WITH FYLNETRA- PEGFILGRASTIM TO OF NEEDLE ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT AS NOT REPORTED. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#1) INFORMATION RECEIVED ON (B)(6)2024. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT ATTACHED WITH THIS CASE. 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 (PFS) WAS 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 CONDUCTED THOROUGH INSPECTIONS AT EACH STAGE - ASSEMBLY, BLISTERING, AND CARTON PACKING FOR LOT NO. 50024003, ENSURING THAT ONLY COMPLIANT PFS UNITS PROCEEDED TO FINAL PACKAGING, SIGNIFICANTLY REDUCING THE LIKELIHOOD OF BENT NEEDLES AT (B)(6). ANALYSIS OF THE COMPLAINT SAMPLE AND BLISTER POCKET DIMENSIONS INDICATED THAT A PFS WITH A SLIGHT BENT NEEDLE SHIELD COULD FIT INTO THE BLISTER PACK AND HENCE, WOULD NOT HAVE BEEN REJECTED AT THE ASSEMBLY STAGE. FURTHERMORE, THE BENT NEEDLE WAS NOTED AFTER THE USER REMOVED THE PFS FROM THE BLISTER. THEREFORE, THE POTENTIAL FOR NEEDLE BENDING DURING HANDLING OR REMOVAL FROM THE BLISTER CANNOT BE ENTIRELY RULED OUT. LAST ACTION TAKEN WITH FYLNETRA- PEGFILGRASTIM TO OF NEEDLE ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT AS NOT REPORTED. THIS CASE WAS CONSIDERED 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 ADVERSE EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT IN A PATIENT (AGE, GENDER AND RACE NOT REPORTED) FROM THE UNITED STATES. THE PATIENT'S AGE AT THE TIME OF EXPERIENCE WAS NOT REPORTED. ON 26-SEP-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACY TECHNICIAN VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENT EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S FYLNETRA- PEGFILGRASTIM. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH FYLNETRA- PEGFILGRASTIM 6/0.6 MG/M (NDC: (B)(4), BATCH NO: 50024003, EXP DATE: 07-DEC-2025, S/N: (B)(6) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CONCOMITANT MEDICATIONS, SMOKER, ALCOHOLIC, ALLERGY, MEDICAL HISTORY, HISTORY OF PROCEDURES, SURGERIES, LABORATORY TESTS AND RECREATIONAL DRUG USE WERE NOT REPORTED. ON UNKNOWN DATE OF (B)(6) 2024, RECEIVED SEALED MEDICATION FROM CARDINAL HEALTH AND ON (B)(6) 2024, WHEN NURSE OPENED THE SYRINGE, SHE OBSERVED THAT THE NEEDLE WAS BENT. LAST ACTION TAKEN WITH FYLNETRA- PEGFILGRASTIM TO OF NEEDLE ISSUE AND NO ADVERSE EVENT WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT WERE UNKNOWN. THE REPORTER ASSESSED THE CAUSALITY OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT AS NOT REPORTED. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2546401 FYLNETRA (PEGFILGRASTIM-PBBK) TYPE 2 PGO KASHIV BIOSCIENCES LLC 50024003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other