BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELEUKO (FILGRASTIM-AYOW) INJECTION

    MDR report key: 20352863 · Received October 2, 2024

    Report

    Report Number
    3011289655-2024-00005
    Event Type
    Malfunction
    Date Received
    October 2, 2024
    Report Date
    November 19, 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

    SYRINGE GOT CLOGGED OR UNABLE TO PUSH THE MEDICATION INTO THE BAGS [DEVICE OCCLUSION] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE OCCLUSION 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 EVENT EXPERIENCE WAS NOT REPORTED. ON 24-SEP-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A PHARMACIST VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S RELEUKO (FILGRASTIM-AYOW). THE PATIENT STARTED TREATMENT WITH RELEUKO (FILGRASTIM-AYOW) 300 MCG/0.5ML SUBCUTANEOUS (NDC: 70121-1568-1, LOT: 30023003, EXPIRY DATE: 30-JUN-2025), (DOSE, FREQUENCY AND THERAPY DATES NOT REPORTED) FOR AN UNKNOWN INDICATION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CURRENT CONDITIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES, HISTORY OF ALLERGIES, SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, ON AN UNKNOWN DATE EXPERIENCED EVENT IN IV ROOM USING THE SYRINGE TO MAKE A DOSE IN IV BAG. THE SYRINGE GOT CLOGGED OR UNABLE TO PUSH THE MEDICATION INTO THE BAGS. FURTHER STATED THAT ON 29-AUG-2024 THEY RECEIVED SEALED MEDICATION FROM AMERISOURCE BERGAN AND ON 23-SEP-2024 WHEN PHARMACY TECHNICIAN USING THE SYRINGE TO MAKE A DOSE IN IV BAG, THEY NOTICED THAT SYRINGE GOT CLOGGED OR UNABLE TO PUSH THE MEDICATION INTO THE BAGS. LAST ACTION TAKEN WITH RELEUKO IN RELATION TO DEVICE OCCLUSION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE OCCLUSION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER PROVIDED THE CAUSALITY OF DEVICE OCCLUSION AND NO ADVERSE EVENT WITH RELEUKO AS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Description of Event or Problem · 0

    SYRINGE GOT CLOGGED OR UNABLE TO PUSH THE MEDICATION INTO THE BAGS [DEVICE OCCLUSION], NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE OCCLUSION 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 EVENT EXPERIENCE WAS NOT REPORTED. ON (B)(6) 2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM A PHARMACIST VIA AN EMAIL CONCERNING THE ABOVE-MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S RELEUKO (FILGRASTIM-AYOW). THE PATIENT STARTED TREATMENT WITH RELEUKO (FILGRASTIM-AYOW) 300 MCG/0.5ML SUBCUTANEOUS (NDC: 70121-1568-1, LOT: 30023003, EXPIRY DATE: 30-JUN-2025) (DOSE, FREQUENCY AND THERAPY DATES NOT REPORTED) FOR AN UNKNOWN INDICATION. CO-SUSPECT MEDICATION, CONCOMITANT MEDICATION, CURRENT CONDITIONS, MEDICAL HISTORY, HISTORY OF PROCEDURES, HISTORY OF ALLERGIES, SMOKING/ALCOHOL CONSUMPTION, RECREATIONAL DRUG USE, AND LABORATORY TESTS WERE NOT REPORTED. IT WAS REPORTED THAT, ON AN UNKNOWN DATE EXPERIENCED EVENT IN IV ROOM USING THE SYRINGE TO MAKE A DOSE IN IV BAG. THE SYRINGE GOT CLOGGED OR UNABLE TO PUSH THE MEDICATION INTO THE BAGS. FURTHER STATED THAT ON (B)(6) 2024, THEY RECEIVED SEALED MEDICATION FROM AMERISOURCE BERGAN AND ON (B)(6) 2024, WHEN PHARMACY TECHNICIAN USING THE SYRINGE TO MAKE A DOSE IN IV BAG, THEY NOTICED THAT SYRINGE GOT CLOGGED OR UNABLE TO PUSH THE MEDICATION INTO THE BAGS. LAST ACTION TAKEN WITH RELEUKO IN RELATION TO DEVICE OCCLUSION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE OCCLUSION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER PROVIDED THE CAUSALITY OF DEVICE OCCLUSION AND NO ADVERSE EVENT WITH RELEUKO AS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. FOLLOW UP (#1) INFORMATION WAS RECEIVED ON 03-OCT-2024: NON-SIGNIFICANT FOLLOW UP (#1) INFORMATION WAS RECEIVED FROM THE PHARMACIST VIA A TELEPHONE CALL. ADDITIONAL INFORMATION INCLUDED NARRATIVE WAS UPDATED. IT WAS REPORTED THAT, THE PHARMACIST READ THE PRODUCT'S INSTRUCTION FOR USE PRIOR TO USING THE PREFILLED SYRINGE. THE PHARMACIST WAS AWARE THAT THE PREFILLED SYRINGE (PFS) WAS INTENDED FOR SUBCUTANEOUS USE ONLY. THE REPORTER WAS NOT AWARE WHY WAS AN ADDITIONAL 18-GUAGE NEEDLE USED ON THE PREFILLED SYRINGE TO INJECT THE PRODUCT INTO IV BAGS. IT WAS FURTHER REPORTED THAT, THEY HAVE USED PREFILLED SYRINGE FOR INTRAVENOUS USE IN THE PAST. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 13-NOV-2024. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT. INVESTIGATION CONFIRMS THAT ROBUST CONTROLS AND PROCEDURES ARE IN PLACE TO IDENTIFY AND REJECT ANY ABNORMALITIES OBSERVED DURING MANUFACTURING AND PACKAGING OF LOT NO: 30023003. GLASS SYRINGES WERE RECEIVED WITH INTENDED NEEDLE QUALITY FROM THE SUPPLIER. TRAINED PERSONNEL CONDUCTED VISUAL INSPECTIONS AFTER FILLING, ASSEMBLY AND PACKAGING, FINDING NO INSTANCES OF DAMAGE NEEDLE OR PARTICULATE MATTERS, WHICH INDICATES A REMOTE POSSIBILITY OF TRANSFERRING PPS WITH DAMAGED NEEDLE OR PARTICULATE MATTERS WHICH MAY BE CLOGGED DURING THE ADMINISTRATION FROM (B)(6). THE ROOT CAUSE WAS IDENTIFIED AS AN ADMINISTRATION ERROR AT THE PHARMACY, WHERE THE SYRINGE INTENDED FOR SUBCUTANEOUS USE WAS USED FOR INTRAVENOUS ADMINISTRATION WITH AN 18-GAUGE NEEDLE. HENCE, THERE IS A CHANCE THAT THE SYRINGE NEEDLE TIP MIGHT HAVE BENT / DEFORMED WHILE ATTACHING 18-GAUGE NEEDLE OVER THE 27-GAUGE PPS NEEDLE, CONSEQUENTLY, AFFECTED THE SYRINGE'S PERFORMANCE I.E., SYRINGE CLOGGING. ALTHOUGH THIS IS THE FIRST MARKET COMPLAINT OF ITS KIND, EFFECTIVE CONTROLS, INCLUDING 100% INSPECTION OF MEDICATION UNITS, SUGGEST THAT THE INCIDENT IS ISOLATED. OF THE (B)(4) DISTRIBUTED PPS UNITS FROM LOT NO: 30023003, ONLY ONE COMPLAINT HAS BEEN RECEIVED REGARDING THE NEEDLE CLOGGED, WITH QUALITY CHECKS CONFIRMING THE PRODUCT'S INTENDED QUALITY AND EFFICACY. ADDITIONALLY, IT IS RECOMMENDED TO ADHERE TO THE PRODUCT'S INTENDED SUBCUTANEOUS USE WITHOUT ATTACHING ANY ADDITIONAL NEEDLE. LAST ACTION TAKEN WITH RELEUKO IN RELATION TO DEVICE OCCLUSION AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE OCCLUSION AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER PROVIDED THE CAUSALITY OF DEVICE OCCLUSION AND NO ADVERSE EVENT WITH RELEUKO AS NOT REPORTED. 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
    35756 RELEUKO (FILGRASTIM-AYOW) INJECTION TYPE 2 PGO KASHIV BIOSCIENCES LLC 30023003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other