BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL TIP CONV PAK

    MDR report key: 20339976 · Received September 30, 2024

    Report

    Report Number
    9610847-2024-00285
    Event Type
    Malfunction
    Date Received
    September 30, 2024
    Date of Event
    September 3, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    00382903056170
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 3 PHOTO AND 1 SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT A PARTICLE THAT LOOKS LIKE A WOOD SPLINTER ON THE PLUNGER. BD DETERMINED THAT THE IDENTIFICATION OF THE MATERIAL IS MOST LIKELY DERIVATIVE OF POLYTETRAFLUROETHYLENE (PTFE). 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 20ML LL TIP CONV PAK HAD FOREIGN MATTER. IT WAS REPORTED BY CUSTOMER THAT THERE IS A WOOD SPLINTER IN THE SILICONE ON THE PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THERE IS A WOOD SPLINTER IN THE SILICONE ON THE PLUNGER. ITEM REF# (B)(4), LOT NUMBER: 4120274, EXPIRATION: 2029-04-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40664 BD SYRINGE 20ML LL TIP CONV PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4120274 00382903056170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown