BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 24189335 · Received January 27, 2026

    Report

    Report Number
    1911916-2026-00042
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 21, 2026
    Report Date
    February 3, 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
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A SYRINGE WAS REPORTED TO CONTAIN BLACK SPOTS AT THE TIP. TO SUPPORT THE INVESTIGATION, ONE SAMPLE IN AN OPENED BLISTER PACKAGE AND TWO PHOTOGRAPHS WERE RECEIVED AND EVALUATED BY THE QUALITY TEAM. VISUAL INSPECTION OF THE RETURNED SAMPLE IDENTIFIED FOUR EMBEDDED DARK SPECKS AT THE BOTTOM OF THE SYRINGE BARREL. THE PHOTOGRAPHS PROVIDED CORRESPOND TO THE SAMPLE RECEIVED, AND NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED SPECKS ARE CONSISTENT WITH DEGRADED RESIN, WHICH CAN OCCUR DURING INJECTION MOLDING AT START UP OR INTERMITTENTLY AND MAY DISLODGE AND BECOME INCORPORATED INTO MOLDED COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309653, LOT 5212999. THIS REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL IN PROCESS AND FINAL INSPECTIONS MET SPECIFICATION REQUIREMENTS, AND NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT TO DATE. BASED ON THE INVESTIGATION AND THE RETURNED SAMPLE EVALUATION, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. DESCRIPTION: MATERIAL: ON (B)(6) 2026, ONE BD 50 ML SYRINGE LUER-LOK TIP (REF 309653) CONTAINED BLACK SPOTS AT THE SYRINGE TIP. LOT 5212999 EXP 2030-07-31, NOT UTILIZED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251793 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5212999 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown