BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 21758888 · Received April 2, 2025

    Report

    Report Number
    1213809-2025-00232
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 14, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP REPORT FOR CORRECTION. LOT # WAS INCORRECT IN THE INITIAL MDR. ALL LOT NUMBERS WERE FILED APPROPRIATELY. PLEASE REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    MATERIAL: 309605, BATCH#: 4262197, UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. CUSTOMER HAS NOTED BLACK RESIDUE ON THE STOPPER OF SKU#: 309605. THE HAVE RETAINED APPROXIMATELY 5-6 INDIVIDUAL SYRINGES WITH THIS RESIDUE. THE RESIDUE WAS TESTED AND FOUND TO BE SILICON. THEY ALSO OBSERVED A FEW INSTANCES OF SMALL, WHITE PARTICLES ON THE INSIDE OF A FEW SYRINGES AS WELL. LOT#: 4122257, 4214769, 4214768, 4192356, 4214780, AND 42 62197.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846771 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS INCORRECT ENTRY 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown