BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELEUKO (FILGRASTIM-AYOW) INJECTION

    MDR report key: 20045968 · Received August 23, 2024

    Report

    Report Number
    3011289655-2024-00003
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 13, 2024
    Report Date
    October 21, 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

    ENTIRE "CLEAR SAFETY GUARD" FELL OFF THE PREFILLED SYRINGE [DEVICE SAFETY FEATURE ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT IN AN UNKNOWN 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 13-AUG-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). FOLLOW-UP (#01) INFORMATION RECEIVED ON 15-AUG-2024. NON-SIGNIFICANT INFORMATION RECEIVED FROM A PHARMACIST VIA AN EMAIL. ADDITIONAL INFORMATION INCLUDED REPORTER ADDRESS WAS UPDATED, AND SUSPECT DOSE DESCRIPTION AND ROUTE OF ADMINISTRATION WAS ADDED. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH RELEUKO (FILGRASTIM-AYOW) 300 MCG/0.5ML SUBCUTANEOUS (NDC: 70121-1568-1, LOT: 30023003) (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, ABOUT A DEFECTIVE PRODUCT INVOLVING YOUR MEDICATION RELEUKO (FILGRASTIM-AYOW). ON 13-JUL-2024, ONE OF OUR NURSES WAS ADMINISTERING A DOSE OF RELEUKO 300 MCG TO A PATIENT AND IN THE PROCESS THE ENTIRE CLEAR SAFETY GUARD FELL OFF THE PREFILLED SYRINGE. THE NURSE ATTEMPTED TO PUT THE SAFETY GUARD BACK ONTO THE SYRINGE AND ADMINISTER THE DOSE; THE ADMINISTRATION WAS SUCCESSFUL, BUT THIS POSED A SIGNIFICANT RISK OF NEEDLE STICK INJURY TO THE NURSE. IT DID NOT LOOK LIKE THE PRODUCT HAD BEEN PREVIOUSLY OPENED OR DAMAGED IN THE PACKAGING. LAST ACTION TAKEN WITH RELEUKO IN RELATION TO DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER PROVIDED THE CAUSALITY OF DEVICE SAFETY FEATURE ISSUE 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

    ENTIRE "CLEAR SAFETY GUARD" FELL OFF THE PREFILLED SYRINGE [DEVICE SAFETY FEATURE ISSUE] NO ADVERSE EVENT [NO ADVERSE EVENT] CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS OF DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT IN AN UNKNOWN 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 13-AUG-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). FOLLOW-UP (#01) INFORMATION RECEIVED ON 15-AUG-2024. NON-SIGNIFICANT INFORMATION RECEIVED FROM A PHARMACIST VIA AN EMAIL. ADDITIONAL INFORMATION INCLUDED REPORTER ADDRESS WAS UPDATED, AND SUSPECT DOSE DESCRIPTION AND ROUTE OF ADMINISTRATION WAS ADDED. ON AN UNKNOWN DATE, THE PATIENT STARTED TREATMENT WITH RELEUKO (FILGRASTIM-AYOW) 300 MCG/0.5ML SUBCUTANEOUS (NDC: 70121-1568-1, LOT: 30023003) (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, ABOUT A DEFECTIVE PRODUCT INVOLVING YOUR MEDICATION RELEUKO (FILGRASTIM-AYOW). ON 13-JUL-2024, ONE OF OUR NURSES WAS ADMINISTERING A DOSE OF RELEUKO 300 MCG TO A PATIENT AND IN THE PROCESS THE ENTIRE CLEAR SAFETY GUARD FELL OFF THE PREFILLED SYRINGE. THE NURSE ATTEMPTED TO PUT THE SAFETY GUARD BACK ONTO THE SYRINGE AND ADMINISTER THE DOSE; THE ADMINISTRATION WAS SUCCESSFUL, BUT THIS POSED A SIGNIFICANT RISK OF NEEDLE STICK INJURY TO THE NURSE. IT DID NOT LOOK LIKE THE PRODUCT HAD BEEN PREVIOUSLY OPENED OR DAMAGED IN THE PACKAGING. LAST ACTION TAKEN WITH RELEUKO IN RELATION TO DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER PROVIDED THE CAUSALITY OF DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT WITH RELEUKO AS NOT REPORTED. THIS CASE WAS CONSIDERED AS SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 16-OCT-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 13-AUG-2024, AMNEAL RECEIVED A COMPLAINT VIA MAIL FROM PHARMACIST, REGARDING ENTIRE ¿CLEAR SAFETY GUARD¿ FELL OFF THE PREFILLED SYRINGE. FOR PRECISE INVESTIGATION, FOLLOW-UP MAILS HAVE BEEN MADE BY AMNEAL TO GET THE ADDITIONAL INFORMATION. ON 21-AUG-2024, THE CALL WAS ANSWERED BY THE COMPLAINANT AS THERE WAS NO COMPLAINT SAMPLE PICTURES AND THERE WAS NO DEFORMITY OBSERVED IN SAFETY GUARD PHARMACIST WAS NOT AWARE ABOUT THE UNITS THEY RECEIVED AND THEY USED SINGLE DOSED 300 MCG, AND IT WAS AFFECTED AND THE THE SYRINGE WAS HANDLED IN A USUAL MANNER. 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. 30023003. 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 KASHIV BIOSCIENCES, LLC, CHICAGO. WHILE THIS MARKET COMPLAINT IS THE FIRST OF ITS KIND, EFFECTIVE CONTROLS, INCLUDING 100% INSPECTION OF MEDICATION UNITS, SUGGEST THAT THE INCIDENT IS ISOLATED. OF THE 6,120 DISTRIBUTED PFS UNITS FROM LOT NO. 30023003, ONLY ONE COMPLAINT HAS BEEN RECEIVED REGARDING THE SAFETY DEVICE, WITH QUALITY CHECKS CONFIRMING THE PRODUCT'S INTENDED QUALITY AND EFFICACY. AWARENESS TRAINING HAS BEEN PROVIDED TO PERSONNEL TO ENHANCE VIGILANCE DURING VISUAL INSPECTIONS. THERE HAVE BEEN NO ADVERSE EFFECTS ON PATIENT SAFETY; HOWEVER, FUTURE USE OF ANY BROKEN OR DAMAGED PFS SHOULD BE AVOIDED, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). LAST ACTION TAKEN WITH RELEUKO IN RELATION TO DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT WAS NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF DEVICE SAFETY FEATURE ISSUE AND NO ADVERSE EVENT WAS UNKNOWN. THE REPORTER PROVIDED THE CAUSALITY OF DEVICE SAFETY FEATURE ISSUE 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
    1363095 RELEUKO (FILGRASTIM-AYOW) INJECTION TYPE 2 PGO KASHIV BIOSCIENCES LLC 30023003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other