BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 21385896 · Received February 14, 2025

    Report

    Report Number
    9610847-2025-00025
    Event Type
    Malfunction
    Date Received
    February 14, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 6, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    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

    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 6 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE PAST STOPPER WAS CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT IN ALL THE PHOTOS IT CAN BE SEEN THAT FLUID IS LEAKING PAST THE STOPPER. BD DETERMINED THAT THE POTENTIAL CAUSE OF THE FAILURE WAS 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK LEAKAGE PAST STOPPER IT WAS REPORTED BY THE CUSTOMER THAT HAD 27 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: 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. WE CANNOT RETURN THE SAMPLES DUE TO THE NATURE OF WHAT IS IN THE SYRINGES UNFORTUNATELY. WE HAD LEAKY SYRINGES FROM THE SAME BATCH ON BOTH THE 29TH AND 30TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1117465 BD SYRINGE 5ML LL TIP BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4213053

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown