BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELEUKO (FILGRASTIM-AYOW) INJECTION

    MDR report key: 18578591 · Received January 25, 2024

    Report

    Report Number
    3011289655-2024-00002
    Event Type
    Malfunction
    Date Received
    January 25, 2024
    Date of Event
    January 14, 2024
    Report Date
    March 15, 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 LODGED INTO THE PATIENT¿S SUBCUTANEOUS ABDOMINAL TISSUE [SOFT TISSUE FOREIGN BODY]. THE NEEDLE CAME OFF THE SYRINGE AND REMAINED LODGED INTO THE PATIENT¿S SUBCUTANEOUS ABDOMINAL TISSUE [NEEDLE ISSUE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS ADVERSE EVENTS OF SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE 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 THE PHARMACIST VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE BEING ADMINISTERED AMNEAL'S RELEUKO. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH RELEUKO 300 MCG/0.5 ML VIA SUBCUTANEOUS (NDC: 70121-1568-1, BATCH NO: 30123001, EXP DATE: APR-2025) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CONCOMITANT MEDICATIONS, SMOKING AND ALCOHOL HISTORY, ALLERGY, MEDICAL HISTORY, HISTORY OF PROCEDURES, SURGERIES, LABORATORY TESTS AND RECREATIONAL DRUG USE WERE NOT REPORTED. IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE NURSE INJECTED THE PATIENT SUBCUTANEOUSLY INTO THE PATIENT¿S ABDOMEN, AND THE NEEDLE BROKE OFF FROM THE SYRINGE AND REMAINED LODGED INTO THE PATIENT¿S SUBCUTANEOUS ABDOMINAL TISSUE. AN ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE BUT WAS UNSUCCESSFUL. IT WAS DETERMINED BY HEALTH CARE PROVIDER THAT BEST COURSE OF ACTION FOR PATIENT WAS TO LEAVE THE NEEDLE. ON (B)(6) 2024, DURING FOLLOW UP WITH PHARMACIST, ADDITIONAL INFORMATION WAS RECEIVED. NEW INFORMATION INCLUDED THERAPY DETAILS AND EVENT DETAILS. ACCORDING TO THE PHARMACIST, ON (B)(6) 2024, THE PATIENT WAS SCHEDULED TO RECEIVE A TOTAL OF 1200 MCG, OVER A NON-SPECIFIED DURATION. ADMINISTRATION OF THE 1ST DOSE (300 MCG) AND 2ND DOSE (300 MCG) OF THE PRODUCT WENT WELL, WITHOUT ANY ISSUE. DURING THE ADMINISTRATION OF THE 3RD DOSE (300 MCG) AND UPON EXITING THE POINT OF ADMINISTRATION, THE NEEDLE OF THE PRE-FILLED SYRINGE BROKE. BASED ON THE INFORMATION PROVIDED BY THE PHARMACIST, THE NEEDLE BROKE OFF AT THE END AS THE SPRING MECHANISM ENGAGED AND THE PLASTIC PART REMAINED, BUT THE NEEDLE SHARP WAS NO LONGER THERE. THE DOSE WAS NOT THOUGHT TO HAVE BEEN PROVIDED BEFORE BREAKAGE. FOLLOWING THE BREAKAGE OF THE NEEDLE, THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) TO ASSESS THE POSSIBILITY OF REMOVING THE NEEDLE. VISUAL EXAMINATION AND SCANS WERE PREFORMED TO LOCATE THE NEEDLE. HOWEVER, THE NEEDLE WAS DETERMINED TO BE LOST IN THE ABDOMEN TISSUE. THE NEEDLE WAS NOT REMOVED AND LEFT IN THE PATIENT. THE PHARMACIST CONFIRMED THAT NO ADVERSE EVENTS WERE NOTED, AND THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT OR REACTIONS. NO OTHER TREATMENT WAS PROVIDED, AND PATIENT WAS NOT ADMITTED OVERNIGHT IN THE HOSPITAL. ALSO, THE PHARMACIST CONFIRMED THAT THIS WAS NOT THE FIRST TIME, THE FACILITY, WHERE THIS INCIDENT OCCURRED, USED AMNEAL'S FILGRASTIM PRODUCT AND THE SAMPLE IS AVAILABLE FOR RETURN. THE COMPLAINT SAMPLE PHOTOS WERE PROVIDED VIA A FOLLOW UP EMAIL COMMUNICATION. ON (B)(6) 2024, FOLLOW UP INFORMATION RECEIVED FROM PHARMACIST VIA AN EMAIL. NEW INFORMATION INCLUDED PRODUCT STORAGE CONDITION, EXPIRY DATE (UPDATED) AND REPORTER'S ADDRESS. THE PATIENT INFORMATION WAS NOT PROVIDED AS THE PATIENT WISHED TO REMAIN ANONYMOUS. THE PRODUCT WAS STORED IN FRIDGE UNTIL THE TIME OF DISPENSE TO BE ADMINISTERED TO THE PATIENT. EXPIRY DATE OF THE PRODUCT UPDATED TO 30-APR-2025. LAST ACTION TAKEN WITH RELEUKO FOR EVENTS SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE WAS NOT RESOLVED. THIS CASE IS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE IS EXPEDITED.

    Description of Event or Problem · 0

    NEEDLE LODGED INTO THE PATIENT¿S SUBCUTANEOUS ABDOMINAL TISSUE [SOFT TISSUE FOREIGN BODY]. THE NEEDLE CAME OFF THE SYRINGE AND REMAINED LODGED INTO THE PATIENT¿S SUBCUTANEOUS ABDOMINAL TISSUE [NEEDLE ISSUE]. CASE NARRATIVE: THIS INITIAL SPONTANEOUS REPORT CONCERNS ADVERSE EVENTS OF SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE 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 THE PHARMACIST VIA AN EMAIL CONCERNING ABOVE MENTIONED ADVERSE EVENTS EXPERIENCED BY THE PATIENT WHILE BEING ADMINISTERED AMNEAL'S RELEUKO. ON AN UNKNOWN DATE, THE PATIENT STARTED THERAPY WITH RELEUKO 300 MCG/0.5 ML VIA SUBCUTANEOUS (NDC: 70121-1568-1, BATCH NO: 30123001, EXP DATE: APR-2025) FOR AN UNKNOWN INDICATION. CONCURRENT CONDITION, CONCOMITANT MEDICATIONS, SMOKING AND ALCOHOL HISTORY, ALLERGY, MEDICAL HISTORY, HISTORY OF PROCEDURES, SURGERIES, LABORATORY TESTS AND RECREATIONAL DRUG USE WERE NOT REPORTED. IT WAS REPORTED THAT, ON AN UNKNOWN DATE, THE NURSE INJECTED THE PATIENT SUBCUTANEOUSLY INTO THE PATIENT¿S ABDOMEN, AND THE NEEDLE BROKE OFF FROM THE SYRINGE AND REMAINED LODGED INTO THE PATIENT¿S SUBCUTANEOUS ABDOMINAL TISSUE. AN ATTEMPT WAS MADE TO RETRIEVE THE NEEDLE BUT WAS UNSUCCESSFUL. IT WAS DETERMINED BY HEALTH CARE PROVIDER THAT BEST COURSE OF ACTION FOR PATIENT WAS TO LEAVE THE NEEDLE. ON (B)(6) 2024, DURING FOLLOW UP WITH PHARMACIST, ADDITIONAL INFORMATION WAS RECEIVED. NEW INFORMATION INCLUDED THERAPY DETAILS AND EVENT DETAILS. ACCORDING TO THE PHARMACIST, ON (B)(6) 2024, THE PATIENT WAS SCHEDULED TO RECEIVE A TOTAL OF 1200 MCG, OVER A NON-SPECIFIED DURATION. ADMINISTRATION OF THE 1ST DOSE (300 MCG) AND 2ND DOSE (300 MCG) OF THE PRODUCT WENT WELL, WITHOUT ANY ISSUE. DURING THE ADMINISTRATION OF THE 3RD DOSE (300 MCG) AND UPON EXITING THE POINT OF ADMINISTRATION, THE NEEDLE OF THE PRE-FILLED SYRINGE BROKE. BASED ON THE INFORMATION PROVIDED BY THE PHARMACIST, THE NEEDLE BROKE OFF AT THE END AS THE SPRING MECHANISM ENGAGED AND THE PLASTIC PART REMAINED, BUT THE NEEDLE SHARP WAS NO LONGER THERE. THE DOSE WAS NOT THOUGHT TO HAVE BEEN PROVIDED BEFORE BREAKAGE. FOLLOWING THE BREAKAGE OF THE NEEDLE, THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) TO ASSESS THE POSSIBILITY OF REMOVING THE NEEDLE. VISUAL EXAMINATION AND SCANS WERE PREFORMED TO LOCATE THE NEEDLE. HOWEVER, THE NEEDLE WAS DETERMINED TO BE LOST IN THE ABDOMEN TISSUE. THE NEEDLE WAS NOT REMOVED AND LEFT IN THE PATIENT. THE PHARMACIST CONFIRMED THAT NO ADVERSE EVENTS WERE NOTED, AND THE PATIENT DID NOT EXPERIENCE ANY DISCOMFORT OR REACTIONS. NO OTHER TREATMENT WAS PROVIDED, AND PATIENT WAS NOT ADMITTED OVERNIGHT IN THE HOSPITAL. ALSO, THE PHARMACIST CONFIRMED THAT THIS WAS NOT THE FIRST TIME, THE FACILITY, WHERE THIS INCIDENT OCCURRED, USED AMNEAL'S FILGRASTIM PRODUCT AND THE SAMPLE IS AVAILABLE FOR RETURN. THE COMPLAINT SAMPLE PHOTOS WERE PROVIDED VIA A FOLLOW UP EMAIL COMMUNICATION. ON 23-JAN-2024, FOLLOW UP INFORMATION RECEIVED FROM PHARMACIST VIA AN EMAIL. NEW INFORMATION INCLUDED PRODUCT STORAGE CONDITION, EXPIRY DATE (UPDATED) AND REPORTER'S ADDRESS. THE PATIENT INFORMATION WAS NOT PROVIDED AS THE PATIENT WISHED TO REMAIN ANONYMOUS. THE PRODUCT WAS STORED IN FRIDGE UNTIL THE TIME OF DISPENSE TO BE ADMINISTERED TO THE PATIENT. EXPIRY DATE OF THE PRODUCT UPDATED TO 30-APR-2025. LAST ACTION TAKEN WITH RELEUKO FOR EVENTS SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE WAS NOT RESOLVED. THIS CASE IS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE IS EXPEDITED. THIS SIGNIFICANT FOLLOW UP (#3) INFORMATION RECEIVED ON 04-MAR-2024. NEW INFORMATION RECEIVED INCLUDES QA INVESTIGATION REPORT, ATTACHED WITH THIS CASE. ON 18-JAN-2024, COMPLAINT SAMPLE WAS RECEIVED AT KASHIV BIOSCIENCES LLC. IN CONCLUSION, THE COMPREHENSIVE INVESTIGATION INTO THE REPORTED INCIDENT CONCERNING FINISHED PRODUCT LOT NO. 30123001 HAS CONFIRMED THE ADHERENCE TO APPROVED BATCH RECORDS DURING MANUFACTURING AND PACKING AT KASHIV BIOSCIENCES, LLC, CHICAGO SITE. THE IMPLEMENTATION OF ROBUST CONTROLS AND MEASURES EFFECTIVELY DETECTS AND REJECTS DEFECTIVE PRE-FILLED SYRINGES. NOTABLY, THE PROTECTIVE NEEDLE SHIELD REMAINS INTACT THROUGHOUT ALL OPERATIONS, SIGNIFICANTLY REDUCING THE RISK OF TRANSFERRING DAMAGED PRE-FILLED SYRINGE. FURTHERMORE, THE EXAMINATION OF THE SYRINGE BARREL MANUFACTURING PROCESS BY OMPI AMERICA INC. HAS VALIDATED THAT SYRINGE BARRELS MEET DEFINED PARAMETERS AND UNDERGO STRINGENT INCOMING CONTROLS, ESPECIALLY CONCERNING NEEDLES. NO INSTANCES OF OUT-OF-SPECIFICATION (OOS) OCCURRENCES, PROCESS DEVIATIONS OR ABNORMAL EVENTS ASSOCIATED WITH THE REPORTED INCIDENTS WERE IDENTIFIED. THE SYRINGE IN QUESTION REMAINS FULLY COMPLIANT WITH SPECIFICATIONS, AND NO NONCONFORMITIES HAVE BEEN DETECTED. IN ADDITION, THE INVESTIGATION HAS REVEALED THAT THE NEEDLE BREAKAGE OCCURRED DURING THE SYRINGE'S EXIT THE WHILE THE PATIENT. THE BROKEN NEEDLE WAS FOUND NEAR THE NEEDLE AND SYRINGE ATTACHMENT PORTION. CONSEQUENTLY, WHILE MANUFACTURING AND QUALITY CONTROL PROCESS ARE ROBUST, THE POSSIBILITY OF PRODUCT SYRINGE HANDLING DURING ADMINISTRATION CANNOT BE COMPLETELY RULED OUT. LAST ACTION TAKEN WITH RELEUKO FOR EVENTS SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE WERE NOT APPLICABLE. DE-CHALLENGE AND RE-CHALLENGE WERE NOT APPLICABLE. THE OUTCOME OF EVENTS SOFT TISSUE FOREIGN BODY AND NEEDLE ISSUE WAS NOT RESOLVED. THIS CASE IS CONSIDERED SERIOUS. THE REPORTABILITY OF THIS CASE IS 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
    1233179 RELEUKO (FILGRASTIM-AYOW) INJECTION TYPE 3 PGO KASHIV BIOSCIENCES LLC 30123001

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other