BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 24897103 · Received April 16, 2026

    Report

    Report Number
    9610847-2026-00167
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 16, 2026
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    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

    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 BY A CUSTOMER THAT ONE SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE, AND ONE SYRINGE HAD EXCESSIVELY SLANTED SYRINGE MARKINGS. COMPLAINT VIA EMAIL. ON 03/31/2026, DURING VISUAL INSPECTION OF LOT: 20260325-2668C6, ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) -1, ONE SYRINGE WAS FOUND TO CONTAIN A FOREIGN PARTICULATE AND ONE SYRINGE HAD EXCESSIVELY SLANTED SYRINGE MARKINGS. THESE UNITS ARE AVAILABLE FOR RETURN. DETAILS FOR YOUR INVESTIGATION: PRODUCT: STERILE SYRINGE TRAY 5ML LOT NUMBER: 5174808/5212183/5218656 PART NUMBER: 309703 NUMBER OF DEFECTIVE UNITS: 2 DEFECT TYPE: FOREIGN PARTICULATE AND DEFECTIVE SYRINGE MARKINGS PRODUCT COMPLAINT: (B)(4) PLEASE LET ME KNOW THE RESULTS OF THE INVESTIGATION ADDITIONAL INFORMATION RECEIVED ON 08APR2026: AS TWO ISSUES HAVE BEEN REPORTED¿FOREIGN MATTER AND A SCALE MARKING ISSUE¿PLEASE CLARIFY WHICH SPECIFIC LOT IS ASSOCIATED WITH EACH ISSUE. THE BATCH/LOT NUMBERS PROVIDED ARE 5174808, 5212183, AND 5218656. WITH THREE DIFFERENT LOTS BEING USED FOR THIS BATCH, WE DO NOT KNOW WHICH LOTS ARE THE ONE WITH DEFECTS. THERE ARE ONLY 2 UNITS WITH DEFECTS. THE NUMBERS I HAD LISTED WERE THE TOTAL AMOUNT WE HAD RECEIVED. AS THE AFFECTED QUANTITIES SEEM TO BE HIGH, WOULD YOU LIKE TO RECEIVE A CREDIT? WE DO NOT NEED A CREDIT, AS THE AMOUNT OF UNITS IS ONLY 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507525 SYRINGE 5ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1