BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Syringe, piston

    MDR report key: 23840070 · Received December 18, 2025

    Report

    Report Number
    1035907-2025-00040
    Event Type
    Malfunction
    Date Received
    December 18, 2025
    Report Date
    December 12, 2025
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    00020221260151
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION OF THE ISSUE THAT INCLUDED THE FOLLOWING: RETAINED SAMPLES WERE EXAMINED THAT INCLUDED THE FOLLOWING: TEN SAMPLES WERE CHECKED FOR OD (OUTER DIMENSION) CHECK UNDER MICROSCOPE (X50 MAGNIFICATION). ALL TEN SAMPLES MEET THE DRAWING TOLERANCE SPECIFICATIONS. NO DIMENSIONAL DEFECTS WERE OBSERVED. THE MEASUREMENT RESULTS AT OF 50X MAGINIFICATION WERE WITHIN THE TOLERANCE RANGE. ONE HUNDRED SAMPLES WERE TESTED FOR LIQUID/AIR LEAKAGE TEST (MANUAL). THE SYRINGES WERE FILLED USING SOAPY WATER WHICH HAS THE HIGHEST SURFACTANT ACTIVITY AND REPRESENTS A WORST-CASE CHALLENGE SOLUTION. DURING MANUAL INSPECTION AND OBSERVATION, NO VACUUM/AIR LEAKAGE WAS DETECTED. ALL SAMPLES DEMONSTRATED NORMAL SUCTION OPERATION, NORMAL INJECTION (SPRAY), AND NO LEAKAGE WAS OBSERVED IN ANY TESTED SAMPLES. THIRTY SAMPLES WERE TESTED FOR LIQUID/AIR LEAKAGE USING A NEGATIVE PRESSURE LEAK TEST MACHINE IN ACCORDANCE WITH ISO 8537:2016 ANNEX B, THE TEST METHOD FOR AIR LEAKAGE PAST A SYRINGE PISTON DURING ASPIRATION AND FOR POTENTIAL SEPARATION OF RUBBER STOPPER AND PLUNGER. THE SYRINGES WERE FILLED WITH ¼ VOLUME OF THE SOAPY WATER, THE PLUNGER WAS PULLED ALL THE WAY TO THE MAXIMUM SCALE, AND A NEGATIVE PRESSURE OF -88KPA WAS APPLIED FOR 60 SECONDS. ALL TESTED SAMPLES PASSED THE TEST, WITH NO BACKFLOW, LEAKAGE AND SEPARATION OBSERVED. QUALITY RECORDS REVIEW- THE QUALITY RECORDS RELATED TO, PRODUCT #26015, LOT # 241123 INCLUDING INCOMING INSPECTION REPORT -GASKET, IN-PROCESS INSPECTION REPORT-ASSEMBLY, AND FINAL INSPECTION REPORT WERE REVIEWED. ALL DOCUMENTS WERE FOUND TO BE ACCEPTABLE, AND NO NONCONFORMITIES RELATED TO LIQUID/AIR LEAKAGE WERE IDENTIFIED. FIVE OF THE RETURNED PRODUCTS WERE TESTED FOR VISUAL INSPECTION AND ASPIRATION OF WATER INTO THE SYRINGES. ALL SYRINGES WERE ABLE TO ASPIRATE AND RETAIN THE LIQUID WITHOUT LEAKAGE. THE CUSTOMER FURTHER MENTIONED THAT THE SYRINGES WERE USED FOR PROCEDURES INVOLVING BOTOX, DYSPORT, AND KENALOG. ACCORDING TO THE PRODUCT INSTRUCTIONS FOR USE (IFU) IFU-6 INSTRUCTIONS FOR USE - EXEL INSULIN SYRINGE,THE INTENDED USE OF THIS DEVICE IS FOR SUBCUTANEOUS INJECTION OF INSULIN INTO THE HUMAN PATIENT'S BODY. USE OF THE PRODUCT WITH MEDICATIONS OUTSIDE OF THE INTENDED USE MAY IMPACT PRODUCT PERFORMANCE AND IS NOT VALIDATED. INCOMING INSPECTION HAS BEEN CONDUCTED IN ACCORDANCE WITH SOP-11 INCOMING INSPECTION PROCEDURE. THE BATCH PASS THE INSPECTIONS, AND NO NONCONFORMANCES WERE IDENTIFIED. BASED ON THE INVESTIGATION, THE REPORTED ISSUE COULD NOT BE REPRODUCED. A POSSIBLE CONTRIBUTING FACTOR MAY BE THE USE OF MEDICATION THAT WAS NOT SPECIFIED OR INCLUDED IN THE PRODUCT'S IFU OR INTENDED USE. NO DEFECTS OR ABNORMALITIES WERE FOUND IN THE RETURN PRODUCTS OR THE RETAINED SAMPLES, AND NO NONCONFORMITIES WERE IDENTIFIED. WE HIGHLY RECOMMEND THAT THE CUSTOMER STRICTLY FOLLOW THE GUIDELINES AND INTENDED USE SPECIFIED IN THE PRODUCT IFU. (B)(4)

    Description of Event or Problem · 0

    CUSTOMER REPORTING THAT SEVERAL OF THEIR PROVIDERS HAVE BEEN REPORTING THAT THE SYRINGES IN LOT # 241223 ALL SEEM TO FAIL TO HOLD THEIR CONTENTS AND LEAK PRIOR TO USE. THE LEAK OCCURRED AT THE TIP OF THE NEEDLE. THE SYRINGES WERE USED FOR BOTOX, DYSPORT, AND KENALOG PROCEDURES. THE ISSUE SEEMS TO BE THE STOPPER ON THE PLUNGER-THE PROVIDERS ARE REPORTING THAT THE PLUNGER FEELS VERY LOOSE AND MEDICATION WILL IMMEDIATELY START TO LEAK AFTER BEING DRAWN. THIS ISSUE IS LEADING TO LESS MEDICATION BEING ADMINISTERED FOR PATIENTS. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2207998 Syringe, piston FMF EXELINT INTERNATIONAL, CO. 241223 00020221260151

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown