BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 21404030 · Received February 18, 2025

    Report

    Report Number
    9610847-2025-00028
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 30, 2025
    Report Date
    April 3, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 6 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE PAST STOPPER WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. BD DETERMINED THE MOST LIKELY CAUSE OF THIS FAILURE IS RELATED TO THE ASSEMBLY PROCESS. 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 5ML LL TIP BULK CONVENIENCE PAK LEAKED PAST STOPPER IT WAS REPORTED BY THE CUSTOMER THAT HAD (B)(4) INSTANCES OF LEAKING SYRINGES AT THE RUBBER STOPPER. VERBATIM: WE WERE PREPARING BATCHES OF MEDICATION TODAY USING BD 5ML LUER-LOCK SYRINGES ITEM 309703 AND HAD 27 INSTANCES OF LEAKING SYRINGES AT THE RUBBER STOPPER. ALL SYRINGES CAME FROM LOT 4213053. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO INJURY TO PATIENT OR HEALTHCARE PROFESSIONAL. HAD THE DRUG IN THE SYRINGE BEEN A HAZARDOUS MATERIAL, THE PROFESSIONAL WOULD HAVE BEEN EXPOSED. IF ADMINISTERED TO A PATIENT, STERILITY COULD NOT BE GUARANTEED DUE TO THERE BEING A FLUID PATH TO NON-STERILE SURFACES. 2. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? WE ARE UNABLE TO SEND SAMPLES AS THEY CONTAIN NARCOTICS. 3. DATE OF EVENT JANUARY 29 AND 30TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2670605 BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4213053 30382903097037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown