BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML ST BULK CONVENIENCE PAK

    MDR report key: 18705377 · Received February 14, 2024

    Report

    Report Number
    9610847-2024-00030
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Date of Event
    January 24, 2024
    Report Date
    May 15, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    30382903097013
    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

    OUR QUALITY ENGINEER INSPECTED THE 28 SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF LEAKAGE OTHER WAS NOT CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT THERE WERE NO ABNORMALITIES OR DEFECTS PRESENT. THE SAMPLES WERE TESTED, AND NO LEAKAGE WAS OBSERVED. BD COULD NOT DETERMINE A MANUFACTURING RELATED ROOT CAUSE SINCE THE REPORTED DEFECT WAS NOT CONFIRMED DURING THE EVALUATION OF THE SAMPLE. 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 THESE BATCHES MEET OUR MANUFACTURING SPECIFICATION REQUIREMENTS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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. WE REGRET ANY INCONVENIENCES THIS INCIDENT MAY HAVE CAUSED YOU AND YOUR FACILITY.

    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 1ML ST BULK CONVENIENCE PAK LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CONSUMER THAT WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS: (B)(6) EXP: 2027-09-30 AND (B)(6) EXP: 2027-10-31. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. MEMBER: (B)(4). VENDOR: BECTON DICKINSON (BD) CANADA INC. PRODUCT: SYRINGE, IV, STERILE, 1 ML, PHARMACY BULK TRAY PROVINCE: (B)(6) LOT NUMBER: 3212533 EXPIRY: 2027-10-31 PROBLEM DESCRIPTION: WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS: (B)(6) EXP: 2027-09-30 AND (B)(6) EXP: 2027-10-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442741 BD SYRINGE 1ML ST BULK CONVENIENCE PAK SYRINGE FMF BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3212533 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown