BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24545742 · Received March 9, 2026

    Report

    Report Number
    1911916-2026-00106
    Event Type
    Malfunction
    Date Received
    March 9, 2026
    Date of Event
    February 4, 2026
    Report Date
    March 12, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. MOISTURE WAS REPORTED IN SYRINGES. TO SUPPORT THE INVESTIGATION, THREE SAMPLES IN OPENED BLISTER PACKAGING WERE RECEIVED AND EVALUATED BY THE QUALITY TEAM. VISUAL INSPECTION IDENTIFIED SILICONE LUBRICANT AT THE BOTTOM OF THE SYRINGE BARREL, WHICH IS EXPECTED AND ACCEPTABLE. THE MEDICAL GRADE SILICONE IS INTENTIONALLY APPLIED TO THE INNER BARREL WALL AND RUBBER STOPPER TO FACILITATE SMOOTH PLUNGER MOVEMENT. A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 309653, LOT 5142418, IDENTIFIED NO NONCONFORMANCES DURING THE MANUFACTURING OF THIS LOT. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL PROCESSES AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMERS REPORTED CONDITION WAS CONFIRMED, HOWEVER, THE OBSERVATION CORRESPONDS TO THE PRODUCTS SILICONE LUBRICATION AND IS CONSIDERED ACCEPTABLE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. DESCRIPTION: WE HAVE RECENTLY DISCOVERED MOISTURE IN SEVERAL OF OUR 50 ML LUER-LOCK SYRINGES THAT ARE STORED IN OUR SUPPLY ROOM IN THEIR ORIGINAL PACKAGING AND NOT EXPOSED TO ANY MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35030 LUER-LOK SYRINGE, PISTON FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5142418 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown