BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL HYPO NDL 23GX3/4"

    MDR report key: 24282856 · Received February 6, 2026

    Report

    Report Number
    1035907-2026-00041
    Event Type
    Malfunction
    Date Received
    February 6, 2026
    Report Date
    March 5, 2026
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221264173
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINED SAMPLE INSPECTION: 100 PIECES OF RETAINED SAMPLES OF HYPODERMIC NEEDLES FROM PRODUCT # 26407, LOT # 240401 WERE RETRIEVED FOR VISUAL INSPECTION. ALL COMPONENTS WERE CLEAN AND FREE OF FOREIGN OBJECTS. PRODUCTION PROCESS REVIEW PRODUCTION RECORDS ASSOCIATED WITH PRODUCT # 26407, LOT # 240401 WERE REVIEWED. ALL DOCUMENTS MET THE REQUIREMENTS FOR PRODUCT RELEASE STANDARDS. NO ABNORMALITIES OR NONCONFORMITIES WAS NOTED. (B)(4)

    Additional Manufacturer Narrative · 0

    CMO CONDUCTED AN INVESTIGATION ON PRODUCT # 26407, LOT #240401. THE INVESTIGATION INCLUDED THE FOLLOWING. -PRODUCTION PROCESS INVESTIGATIONPRODUCTION RECORDS FOR PRODUCT # 26407, LOT # 240401 WERE REVIEWED. NO CHANGES TO RAW MATERIALS OR THE PRODUCTION PROCESS WERE IDENTIFIED FOR THIS LOT. THE PRODUCTS WERE ASSEMBLED BY MACHINE, AND NO ABNORMALITIES WERE NOTED DURING PRODUCTION. ALL DOCUMENTATION MEETS THE REQUIREMENTS FOR PRODUCT RELEASE. NO NONCONFORMANCES OR ABNORMALITIES ASSOCIATED WITH THE MANUFACTURING OF THIS BATCH WERE IDENTIFIED. -RETAINED SAMPLES TESTINGONE HUNDRED PIECES OF RETAINED SAMPLES FROM PRODUCT # 26407, LOT # 240401 WERE SUBJECTED TO VISUAL INSPECTION. ALL SAMPLES WERE FOUND TO BE CLEAN AND FREE OF FOREIGN MATERIALS AND WERE COMPLIANT WITH THE ISO 7864:2016 REQUIREMENTS. -INCOMING INSPECTION HAS BEEN PERFORMED IN-HOUSE BY FOLLOWING SOP-11 INCOMING INSPECTION PROCEDURE. THE BATCH PASSED ALL INSPECTION CRITERIA FOR PRODUCT RELEASE. NO NONCONFORMANCES RELATED TO THE LOT WAS NOTED. -PRODUCT IN QUESTION WITH THE FOREIGN MATERIAL WAS NOT RETURNED FOR EVALUATION. THEREFORE, MATERIAL IDENTIFICATION OF THE QUALITY ISSUE COULD NOT BE PERFORMED AS PART OF THIS INVESTIGATION. A REVIEW OF THE RELEVANT MANUFACTURING PROCESS DOCUMENTATION AND THE VISUAL INSPECTION DID NOT REVEAL ANY NONCONFORMITIES. NO ABNORMALITIES OR NONCONFORMITIES WERE IDENTIFIED DURING THE MANUFACTURING OR RETAINED SAMPLES TESTING. THE PHOTOS PROVIDED BY THE END USER WERE REVIEWED AS PART OF THE INVESTIGATION. BASED ON THE VISUAL ASSESSMENT, THE REPORTED FOREIGN MATERIAL APPEARS TO RESEMBLE CHARRED PARTICULATES THAT MAY POTENTIALLY BE GENERATED DURING THE INJECTION MOLDING PROCESS. HOWEVER, THE DEFECTIVE PRODUCT WITH THE FOREIGN PARTICULATES WAS NOT RETURNED FOR EVALUATION. THEREFORE, THE FOREIGN MATERIALS IN THE PRODUCT COULD NOT BE CONFIRMED OR IDENTIFIED. AS A RESULT, THE ROOT CAUSE REMAINS UNCONFIRMED. BASED ON AVAILABLE INFORMATION AND THE RESULTS OF THE INVESTIGATION, THIS COMPLAINT WILL BE CLOSED. ALTHOUGH A CONFIRMED ROOT CAUSE WAS NOT IDENTIFIED, PREVENTIVE MEASURES WERE IMPLEMENTED. ON 11/17/2025, A ROUTINE TRAINING WAS CONDUCTED ON ALL RELEVANT HYPODERMIC NEEDLE WORKSHOP PERSONNEL ON THE FOLLOWING PROCEDURES. - INSPECTION REGULATIONS FOR DISPOSABLE HYPODERMIC NEEDLES (MACHINE ASSEMBLED FOR STANDARD AND NEEDLE STICK PREVENTION TYPES) AND - PROCESS HYGIENE MANAGEMENT SYSTEM. THE TRAINING OCCURRED AFTER THE MANUFACTURE OF PRODUCT # 26407, LOT # 240401 AND THEREFORE DID NOT IMPACT THE INVESTIGATED LOT. THE TRAINING WAS CONDUCTED AS A PREVENTIVE MEASURE TO REINFORCE ADHERENCE TO EXISTING INSPECTION AND HYGIENE REQUIREMENTS TO REDUCE THE POTENTIAL RISK OF FOREIGN PARTICULATE CONTAMINATION. ADDITIONAL INVESTIGATION AND REVIEW ACTIVITIES WAS REQUESTED, INCLUDING REVIEW OF -CURRENT EQUIPMENT CALIBRATION - PROCESS MONITORING CONTROLS -LINE CLEARANCE PROCEDURES. THESE REVIEWS WERE CONDUCTED TO VERIFY CONTINUED MANUFACTURING COMPLIANCE AND TO HELP PREVENT RECURRENCE OF THE REPORTED ISSUE. NO SIMILAR ISSUES WERE IDENTIFIED WITH THIS LOT. (B)(4).

    Description of Event or Problem · 0

    CALLER REPORTED NEEDLE CONTAMINATION. BLACK PARTICLES WERE FOUND ON THE NEEDLE HUB ON A BRAND-NEW NEEDLE., PRODUCT # 26407, LOT # 240401. NO ADVERSE EVENT REPORTED AS THE CONTAMINATION WAS NOTED RIGHT AWAY.

    Description of Event or Problem · 0

    CALLER REPORTED NEEDLE CONTAMINATION. BLACK PARTICLES WERE FOUND ON THE NEEDLE HUB ON A BRAND-NEW NEEDLE., PRODUCT # 26407, LOT # 240401. NO ADVERSE EVENT REPORTED AS THE CONTAMINATION WAS NOTED RIGHT AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94319 EXEL HYPO NDL 23GX3/4" HYPODERMIC NEEDLE FMF EXELINT INTERNATIONAL, CO. 240401 00020221264173

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown