BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 30ML LL TIP CONV PAK

    MDR report key: 20833673 · Received December 3, 2024

    Report

    Report Number
    9610847-2024-00363
    Event Type
    Malfunction
    Date Received
    December 3, 2024
    Date of Event
    October 5, 2024
    Report Date
    January 30, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056187
    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

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 4 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED THAT THERE WAS CARDBOARD DEBRIS WITHIN THE TRAYS OF THE SAMPLES. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO INCORRECT HANDLING OF MATERIALS DURING THE MANUAL LOADING PROCESS OF THE SYRINGES INTO THE TRAYS DURING MANUFACTURING. A RETRAINING OF MANUFACTURING PERSONNEL WAS PERFORMED TO ADDRESS THIS ISSUE. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 30ML LL TIP CONV PAK FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT, DARK PARTICULATE WAS OBSERVED EMBEDDED IN THE BARREL OF A SYRINGE, FOREIGN RED PARTICULATE WAS OBSERVED IN THE TRAY, CARDBOARD DEBRIS WAS OBSERVED INSIDE OF A SYRINGE WITHIN THE TRAY, FOREIGN DARK PARTICULATE WAS OBSERVED ON A SYRINGE WITHIN THE TRAY, A HAIR WAS OBSERVED IN THE TRAY AND CARDBOARD DEBRIS WAS OBSERVED IN THE TRAY. SUP-2024-0035RCC RECEIVED A COMPLAINT VIA EMAIL. A DARK PARTICULATE WAS OBSERVED EMBEDDED IN THE BARREL OF A SYRINGE. A FOREIGN RED PARTICULATE WAS OBSERVED IN THE TRAY. CARDBOARD DEBRIS WAS OBSERVED INSIDE OF A SYRINGE WITHIN THE TRAY. FOREIGN DARK PARTICULATE WAS OBSERVED ON A SYRINGE WITHIN THE TRAY. A HAIR WAS OBSERVED IN THE TRAY. CARDBOARD DEBRIS WAS OBSERVED IN THE TRAY. PRODUCT NUMBER: 305618, LOT NUMBER: 4123948, 4178230.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202121 BD SYRINGE 30ML LL TIP CONV PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4178230 00382903056187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown