BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXEL 2-3ML SYR 25GX1" L-L, W/ LDS

    MDR report key: 22419903 · Received July 7, 2025

    Report

    Report Number
    1035907-2025-00031
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 2, 2025
    Report Date
    July 7, 2025
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221261110
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CMO CONDUCTED AN INVESTIGATION ON PRODUCT#: 26111, LOT#: 210615 AND THE RESULTS ARE AS FOLLOWS: PRODUCTION PROCESS REVIEW: THE BATCH PRODUCTION RECORDS, FACTORY INSPECTION, AND TESTING OF PRODUCTS WERE REVIEWED. ALL DOCUMENTS WERE FOUND TO BE ACCEPTABLE FOR PRODUCT RELEASE, WITH NO ABNORMALITIES OBSERVED. RETAINED SAMPLES TESTING: ONE HUNDRED RETAINED SAMPLES WERE EACH VISUALLY INSPECTED. THE SAMPLES MET THE INSPECTION WITH NO ABNORMALITIES WERE OBSERVED. FIVE SAMPLES WERE RANDOMLY SELECTED FOR SIMULATED ASPIRATION AND INJECTION TESTS. ALL TESTED SAMPLES PASSED THE TESTS WITH NO LEAKAGE OR EJECTION ISSUES WERE FOUND. ADDITIONALLY, AN OBSERVATION WAS PERFORMED ON THE TESTED SAMPLE SYRINGES BY SEPARATING OR DISCONNECTING THE SYRINGE FROM THE NEEDLE HUB. THE SYRINGE'S THREADED PORT AND THE INJECTION NEEDLE HUB WERE FOUND TO BE INTACT AND SECURELY FITTED. THE INCOMING INSPECTION HAS BEEN CONDUCTED ON PRODUCT#: 26111, LOT#: 210615 IN ACCORDANCE WITH SOP-11, INCOMING INSPECTION PROCEDURE. THE LOT PASSED THE INCOMING INSPECTION CRITERIA FOR PRODUCT RELEASE. MINOR NON-CONFORMITY WAS OBSERVED, HOWEVER, THIS WAS DOCUMENTED AND DETERMINED TO BE UNRELATED TO THE REPORTED ISSUE BASE. ON AVAILABLE EVIDENCE. IN SUMMARY, ALL RETAINED SAMPLES WERE FOUND TO BE QUALIFIED FOR PRODUCT RELEASE WITH NO NEEDLE DETACHMENT OR BREAKAGE DETECTED IN THE TESTED SAMPLES. IT IS LIKELY POSSIBLE THAT THE CONNECTION BETWEEN THE SYRINGE'S THREADED PORT AND NEEDLE HUB MAY BE LOOSENED; HOWEVER, THIS COULD NOT BE CONFIRMED BASED ON THE AVAILABLE INFORMATION. THEREFORE, WE WERE NOT ABLE TO DETERMINE THE ROOT CAUSE, AND IT REMAINS UNCONFIRMED.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT WHEN THEY ADMINISTER B12 SHOT, THE SYRINGE WAS LEAKING FROM THE HUB. AFTER DISCARDING THE DEFECTIVE SYRINGE, SHE USED ANOTHER ONE AND THE NEEDLE POPPED-OFF, SO SHE TESTED ANOTHER SYRINGE WITH A LEMON , AND THE NEEDLE POPPED OFF AGAIN IN THE LEMON. THE CUSTOMER MENTIONED THAT NO PATIENTS WERE INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152826 EXEL 2-3ML SYR 25GX1" L-L, W/ LDS SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL, CO. 210615 00020221261110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female