BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL 2-3ML SYR 22GX1" L-L, W/ LDS

    MDR report key: 22986626 · Received September 5, 2025

    Report

    Report Number
    1035907-2025-00035
    Event Type
    Malfunction
    Date Received
    September 5, 2025
    Report Date
    September 4, 2025
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221261028
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN PERFORMED ON PRODUCT # 26102, LOT NUMBER 251014 WHICH INCLUDED THE FOLLOWING: ONE HUNDRED RETAINED SAMPLES WERE VISUALLY INSPECTED. THE INJECTION NEEDLES AND SYRINGES WERE TIGHTLY CONNECTED, AND NO LOOSENING OR FAILURE TO LOCK WAS OBSERVED OR FOUND. TEN SAMPLES WERE RANDOMLY SELECTED, THE NEEDLES WERE SEPARATED FROM THE SYRINGES, AND THE INTERNAL THREADS WERE OBSERVED. THE SYRINGE THREADS WERE FOUND TO BE INTACT WITHOUT ANY DAMAGES. THE SYRINGES COULD BE TIGHTLY CONNECTED WITH THE INJECTION NEEDLES WITHOUT ANY ISSUES. PRODUCTION RECORDS WERE REVIEWED. NO NON-CONFORMANCES OR ABNORMALITIES WERE OBSERVED. THE PRODUCTION PROCESS AND RAW MATERIALS REMAINS UNCHANGED. TESTS WERE CONDUCTED IN ACCORDANCE WITH CLAUSE 6.5 "RESISTANCE TO SEPARATION FROM UNSCREWING" OF THE ISO 80369-7 STANDARD. THE TEST RESULTS MEET THE STANDARD REQUIREMENTS. THE TEST CONNECTION BETWEEN THE NEEDLE HUB AND THE PROTECTIVE CAP WAS EVALUATED. THE PROTECTIVE CAPS WERE FOUND TO BE SECURE AND DOES NOT COME-OFF NATURALLY. AN IMPACT FREE PULLING TEST WAS PERFORMED USING AN INSTRUMENT. THE SEPARATION FORCE DID NOT EXCEEDED 15N. THESE TESTS MEET THE REQUIREMENT ESTABLISHED IN GB15811 & ISO 17864. FURTHERMORE, THE INCOMING INSPECTION OF THIS LOT HAS BEEN PERFORMED BY FOLLOWING SOP-11 INCOMING INSPECTION PROCEDURE. THIS LOT MET THE INSPECTION CRITERIA FOR PRODUCT RELEASE WITH NO ABNORMALITIES OR NON-CONFORMANCES FOUND. THE DEFECTIVE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO DOCUMENTARY EVIDENCE SUCH AS PHOTO OR VIDEO WAS PROVIDED. NO SIMILAR COMPLAINT FROM THIS LOT HAS BEEN REPORTED. IN SUMMARY, WE WERE UNABLE TO DETERMINE THE ROOT CAUSE, AND OR ABLE TO REPLICATE THE REPORTED ISSUE IN OUR INVESTIGATION. WITHOUT THE PHYSICAL DEFECTIVE DEVICE TO EVALUATE AND THE LACK OF DOCUMENTARY EVIDENCE, OUR INVESTIGATION IS QUITE LIMITED. THEREFORE, THE ROOT CAUSE REMAINS UNCONFIRMED AND THIS COMPLAINT IS CONSIDERED CLOSE. (B)(4)

    Description of Event or Problem · 0

    1 FULL BOX SYRINGE EXEL 3CC LL 22X1 100S HAVE AN ISSUE WITH THE LL BEING LOOSE AND NOT TIGHTENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264175 EXEL 2-3ML SYR 22GX1" L-L, W/ LDS SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL, CO. 250104 00020221261028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown