BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50CC LL TIP CONVENIENCE PAK

    MDR report key: 21265078 · Received January 29, 2025

    Report

    Report Number
    9610847-2025-00006
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 4, 2024
    Report Date
    April 9, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903096800
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 9 PHOTOS AND 2 PHYSICAL SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT UNDER 30X MAGNIFICATION IN ONE OF THE SAMPLES A DARK COLORED SPECK WAS OBSERVED 3/8¿ FROM THE SYRINGE BARREL FLANGE THAT MEASURES 1/64¿ IN SIZE. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS THE MOLDING PROCESS. THE EMBEDDED DEGRADED RESIN OCCURS AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE SYSTEM OF THE TOOLING MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 50CC LL TIP CONVENIENCE PAK HAD FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT CARDBOARD DEBRIS WAS OBSERVED IN THE TRAY, INSIDE OF A SYRINGE BARREL AND EMBEDDED IN THE BARREL OF A SYRINGE. A HAIR WAS OBSERVED IN THE TRAY AND OBSERVED IN THE SYRINGE TRAY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. POTENTIAL CARDBOARD DEBRIS WAS OBSERVED EMBEDDED IN THE BARREL OF A SYRINGE. CARDBOARD DEBRIS WAS OBSERVED IN THE TRAY. CARDBOARD DEBRIS WAS OBSERVED INSIDE OF A SYRINGE BARREL. A HAIR WAS OBSERVED IN THE TRAY. A HAIR WAS OBSERVED IN THE SYRINGE TRAY. ITEM - 309680. LOT - 4183640, 4183639.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953620 BD SYRINGE 50CC LL TIP CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4183640 00382903096800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown