BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 22700894 · Received August 4, 2025

    Report

    Report Number
    9610847-2025-00239
    Event Type
    Malfunction
    Date Received
    August 4, 2025
    Date of Event
    June 24, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097037
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 3 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. ANALYSIS OF THE SAMPLE SHOWED THAT THE REPORTED DEFECT OF FOREIGN FIBER CAN BE OBSERVED. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE SINCE NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE OF THE REPORTED FAILURE. 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 5ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT THREE SYRINGES WERE FOUND TO CONTAIN VISIBLE FOREIGN FIBERS. RCC RECEIVED A COMPLAINT VIA EMAIL. ON 24JUN2025, FOR BATCH: MFG-PC004 (B)-024-25, THREE SYRINGES WERE FOUND TO CONTAIN VISIBLE FOREIGN FIBERS AND WERE SUBSEQUENTLY REJECTED. THE DETAILS OF THE FINDINGS ARE AS FOLLOWS: SYRINGE A: WHITE FIBER OBSERVED SYRINGE B: WHITE FIBER OBSERVED SYRINGE C: BLACK FIBER OBSERVED THE CONTAMINATED SYRINGES WERE SUBMITTED TO AN INDEPENDENT THIRD-PARTY LABORATORY FOR PARTICLE CHARACTERIZATION. FINDINGS: THE WHITE FIBER IN SYRINGE A WAS IDENTIFIED AS NATURAL CELLULOSE. THE WHITE FIBER IN SYRINGE B WAS IDENTIFIED AS POLYSTYRENE. THE BLACK FIBER IN SYRINGE C WAS IDENTIFIED AS TEXTILE CELLULOSE. ADDITIONAL INFORMATION RECEIVED ON 22JUL2025 1. COULD YOU PLEASE PROVIDE THE TOTAL NUMBER OF OCCURRENCES FOR EACH REPORTED LOT#? A TOTAL OF 12 SYRINGES WERE REPORTED ACROSS BOTH LOT#: 5093061 AND LOT#: 5072061. UNFORTUNATELY, WE ARE UNABLE TO DETERMINE THE EXACT QUANTITY ATTRIBUTED TO EACH LOT INDIVIDUALLY. 2. WOULD IT BE POSSIBLE TO SEND ANY AVAILABLE SAMPLES FOR OUR INVESTIGATION? SAMPLES WERE SUBMITTED TO A THIRD-PARTY LABORATORY FOR FIBER ANALYSIS. THE FIBERS WERE IDENTIFIED AS NATURAL CELLULOSE, POLYSTYRENE, AND TEXTILE CELLULOSE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205162 BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK STOPCOCK, I.V. SET FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 5072061 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown