BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELEUKO (FILGRASTIM-AYOW) INJECTION

    MDR report key: 20449154 · Received October 15, 2024

    Report

    Report Number
    3011289655-2024-00007
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Report Date
    November 29, 2024
    Manufacturer
    KASHIV BIOSCIENCES LLC
    Product Code
    PGO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NEEDLE APPEARS TO HAVE BEEN BENT PRIOR TO PACKAGING [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 04-OCT-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACIST VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S RELEUKO (FILGRASTIM-AYOW). ADDITIONAL NON-SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 07-OCT-2024 FROM THE PHARMACIST VIA A TELEPHONE CALL. NEW INFORMATION INCLUDED NARRATIVE HAVE BEEN ADDED. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH RELEUKO (FILGRASTIM-AYOW) 480MCG/0.8ML (NDC: 70121-1570-1, LOT NO: 35123003, EXP. DATE: AUG-2025) (DOSE, FREQUENCY, AND THERAPY DATE NOT REPORTED) 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. IT WAS REPORTED THAT, RELEUKO 480 MCG SYRINGE WHOSE NEEDLE APPEARS TO HAVE BEEN BENT PRIOR TO PACKAGING. FURTHER INFORMATION WAS RECEIVED ON 07-OCT-2024 WHICH STATES THAT THEY RECEIVED A SEALED MEDICATION BOX FROM THE WHOLESALER ON 04-SEP-2024 AND THE NURSE OBSERVED THAT THE NEEDLE WAS BENT PRIOR TO ADMINISTRATION. THE REPORTER DENIED TO PROVIDING HOSPITAL DETAILS AND NURSE DETAILS AND REQUESTED FOR THE REPLACEMENT. HE CONFIRMED THAT THEY DID NOT ADMINISTER TO THE PATIENT. UPON ASKING SAMPLE AVAILABILITY HE AGREED TO SEND ONLY SYRINGE BECAUSE HE DISCARDED THE MEDICATION BOX AND AGREED TO SEND COMPLAINT SAMPLE PICTURES. LAST ACTION TAKEN WITH RELEUKO TO 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 DID NOT ASSESS THE CAUSALITY OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT WITH RESPECT TO RELEUKO. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED.

    Description of Event or Problem · 0

    NEEDLE APPEARS TO HAVE BEEN BENT PRIOR TO PACKAGING [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 04-OCT-2024, AMNEAL PHARMACEUTICALS RECEIVED INFORMATION FROM PHARMACIST VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE ON AMNEAL'S RELEUKO (FILGRASTIM-AYOW). ADDITIONAL NON-SIGNIFICANT INFORMATION (#1) WAS RECEIVED ON 07-OCT-2024 FROM THE PHARMACIST VIA A TELEPHONE CALL. NEW INFORMATION INCLUDED; NARRATIVE HAVE BEEN ADDED. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH RELEUKO (FILGRASTIM-AYOW) 480MCG/0.8ML (NDC: 70121-1570-1, LOT NO: 35123003, EXP. DATE: AUG-2025) (DOSE, FREQUENCY, AND THERAPY DATE NOT REPORTED) 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. IT WAS REPORTED THAT, RELEUKO 480 MCG SYRINGE WHOSE NEEDLE APPEARS TO HAVE BEEN BENT PRIOR TO PACKAGING. FURTHER INFORMATION WAS RECEIVED ON 07-OCT-2024 WHICH STATES THAT THEY RECEIVED A SEALED MEDICATION BOX FROM THE WHOLESALER ON 04-SEP-2024 AND THE NURSE OBSERVED THAT THE NEEDLE WAS BENT PRIOR TO ADMINISTRATION. THE REPORTER DENIED TO PROVIDING HOSPITAL DETAILS AND NURSE DETAILS AND REQUESTED FOR THE REPLACEMENT. HE CONFIRMED THAT THEY DID NOT ADMINISTER TO THE PATIENT. UPON ASKING SAMPLE AVAILABILITY HE AGREED TO SEND ONLY SYRINGE BECAUSE HE DISCARDED THE MEDICATION BOX AND AGREED TO SEND COMPLAINT SAMPLE PICTURES. LAST ACTION TAKEN WITH RELEUKO TO 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 DID NOT ASSESS THE CAUSALITY OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT WITH RESPECT TO RELEUKO. THIS CASE WAS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE WAS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#2) INFORMATION RECEIVED ON 27-NOV-2024. NEW INFORMATION RECEIVED INCLUDES INVESTIGATION REPORT, ATTACHED WITH THIS CASE. 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 SECURELY EQUIPPED WITH A SAFETY DEVICE AND PROPERLY PACKAGED TO MINIMIZE DAMAGE RISKS DURING HANDLING AND TRANSIT. TRAINED PERSONNEL CONDUCT THOROUGH INSPECTIONS AT ALL STAGES, I.E., ASSEMBLY, BLISTERING, AND CARTON PACKING ENSURING THAT ONLY COMPLIANT PFS UNITS WERE RELEASED FOR FINAL PACKAGING, THEREBY REDUCING THE LIKELIHOOD OF BENT NEEDLES AT KASHIV BIOSCIENCES, LLC, CHICAGO. FURTHERMORE, THE NEEDLE SHIELD WAS FOUND STRAIGHT WHEN REMOVED FROM THE BLISTER, AND THE COMPLAINANT WAS UNSURE WHETHER EXCESSIVE FORCE WAS APPLIED DURING ITS REMOVAL. GIVEN THE THIN-WALLED NATURE OF THE OMPI SYRINGES, WHICH ARE SUSCEPTIBLE TO BENDING IF THE NEEDLE SHIELD IS NOT REMOVED STRAIGHTLY, THE POSSIBILITY OF NEEDLE BENDING DURING THE REMOVAL PROCESS CANNOT BE ENTIRELY RULED OUT. LAST ACTION TAKEN WITH RELEUKO TO 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 DID NOT ASSESS THE CAUSALITY OF EVENTS OF NEEDLE ISSUE AND NO ADVERSE EVENT WITH RESPECT TO RELEUKO. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30747 RELEUKO (FILGRASTIM-AYOW) INJECTION TYPE 2 PGO KASHIV BIOSCIENCES LLC 35123003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other