BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 20898657 · Received December 10, 2024

    Report

    Report Number
    1213809-2024-00941
    Event Type
    Malfunction
    Date Received
    December 10, 2024
    Date of Event
    November 11, 2024
    Report Date
    February 27, 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
    KS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) SUPPLEMENTAL MDR - FOREIGN MATTER. IT WAS REPORTED THERE WAS A FUZZ-LIKE MATERIAL WAS SEEN INSIDE THE SYRINGE FLOATING IN THE SOLUTION. TO AID IN THE INVESTIGATION, ONE PHOTO AND ONE SAMPLE OF A 10ML LUER LOK SYRINGE, MATERIAL 309605, WAS RECEIVED AND METICULOUSLY EVALUATED BY OUR QUALITY TEAM. THE SYRINGE WAS RECEIVED LOOSE AND FULLY DISASSEMBLED REVEALING MULTIPLE PARTICULATES IN THE FLUID PATH. A LARGE GREY PARTICULATE WAS ALSO FOUND IN A SEPARATE PLASTIC BAG. THE PHOTO SHOWS A FULLY ASSEMBLED LOOSE SYRINGE WITH A WHITE CAP COVERING THE TIP OF THE BARREL. AN UNKNOWN LOOSE GREY PARTICLE IS PRESENT IN THE FLUID PATH WITH A TRANSPARENT FLUID. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309605, LOT 4110189. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED PER REQUIREMENTS WITH NO QUALITY NOTIFICATIONS RELATED TO THE DEFECT REPORTED. THE LOT WAS INSPECTED AND ACCEPTED BASED ON OUR INSPECTION CONTROL PLAN AND APPROVED FOR SHIPMENT. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIALS: 309605. BATCH#: 4110189. 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: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DURING VISUAL INSPECTION OF FINISHED PRODUCT, A FUZZ-LIKE MATERIAL WAS SEEN INSIDE THE SYRINGE FLOATING IN THE SOLUTION NEAR THE TIP OF THE SYRINGE. PRODUCT#: 309605. LOT#: 4110189.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2573222 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4110189 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown