BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL SP125

    MDR report key: 20433215 · Received October 11, 2024

    Report

    Report Number
    1213809-2024-00701
    Event Type
    Malfunction
    Date Received
    October 11, 2024
    Date of Event
    September 18, 2024
    Report Date
    January 6, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIFTY SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. FORTY SAMPLES WERE RECEIVED IN SEALED PACKAGES AND NO DEFECTS WERE OBSERVED. TEN SYRINGES WERE RECEIVED LOOSE AND FOUR OF THEM WERE FOUND TO HAVE AN UNKNOWN GREYISH WHITE PARTICULATE IN THE FLUID PATH. THE PHOTO RECEIVED SHOWS ONE LOOSE SYRINGE WITH THE UNKNOWN GREYISH PARTICULATE IN THE FLUID PATH AS DESCRIBED ABOVE. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS COMPLETED AND DETERMINED THE MOST LIKELY SUBSTANCE TO BE POLYISOBUTYLENE FROM THE RUBBER STOPPER USED IN THE MANUFACTURING PROCESS. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER FLUID PATH DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY, SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4080612. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. 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#: 309646. BATCH NUMBER#: 4080612. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL SP125 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: CUSTOMER STATING, THEY HAVE CONTAMINATED SYRINGES AND PIECES OF RUBBER FROM THE PLUNGER HAVE FALLEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294566 BD SYRINGE 5ML LL SP125 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4080612 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown