BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 21757776 · Received April 2, 2025

    Report

    Report Number
    1213809-2025-00228
    Event Type
    Malfunction
    Date Received
    April 2, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 21, 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

    PR (B)(4) - SUPPLEMENTAL MDR - FOREIGN MATTER. ADDITIONAL INFORMATION: TWO POSSIBLE LOT PROVIDED LOT 4073231 AND LOT 4192355 EVALUATION: TWO PHOTO AND ONE SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON EVALUATION, IT WAS OBSERVED THAT A FULLY ASSEMBLED SYRINGE FILLED WITH TRANSPARENT FLUID, CONTAINING A LARGE INSECT FLOATING IN THE FLUID PATH INSIDE THE BARREL. THE OBSERVED CONDITION IS NON-CONFORMING TO PRODUCT SPECIFICATIONS. THE POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER IN FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. AS CORRECTIVE ACTION, QUALITY ALERT WILL BE SENT TO THE PLANT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4073231 AND 4192355. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    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

    MATERIAL#: 309605, BATCH#: 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. DURING VISUAL INSPECTION OF FINISHED PRODUCT, AN INSECT WAS VISUALIZED INSIDE THE SYRINGE FLOATING IN THE SOLUTION. ITEM NUMBER: 309605, LOT NUMBER: 2000205.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634206 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown