BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 24761541 · Received April 1, 2026

    Report

    Report Number
    1213809-2026-00163
    Event Type
    Malfunction
    Date Received
    April 1, 2026
    Date of Event
    September 16, 2025
    Report Date
    May 27, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C LABEL CONTENT WAS INCORRECT. COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS IS THE OFFICIAL REQUEST FOR INVESTIGATION FOR NON-CONFORMANCE: NC-(B)(4). NC NUMBER NC-(B)(4). CAPA/ACT NUMBER ACT-064862. MM# 10500500 3 ML SYRINGE SUPPLIER MATERIAL (CATALOG) PART NUMBER 309657 SUPPLIER BD PLASTICS IS THE MATERIAL BOUGHT DIRECTLY FROM SUPPLIER? NO THIS IS PURCHASED THROUGH (B)(6). PO NUMBER (B)(4). SUPPLIER LOT NUMBER 5133990 COC OR COA OF THE IMPACTED MATERIAL N/A SUMMARY OF THE DEFECT BASED ON THE NC CONCLUSION (FAILURE MODE / WHEN, WHO, WHERE, HOW, WHAT) DESCRIPTION OF ISSUE: APN-044452: INITIATE THE SUPPLIER INVESTIGATION FOR A MISLABELED CONTAINER OF 3ML SYRINGES SHIPPED FROM TO PRINCE STERILIZATION. ONE CARTON FROM THE MASTER PACK WAS LABELED AS 5 ML, HOWEVER, THE INNER CONTAINER CONTAINED 3 ML SYRINGES AND CONTAINED ONLY 125 QUANTITIES INSTEAD OF 200. IS THE AFFECTED MATERIAL AVAILABLE NO: THEY WERE DISPOSITIONED AS SCRAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227991 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5133990 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1