BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 27X1/2

    MDR report key: 21079952 · Received January 6, 2025

    Report

    Report Number
    2243072-2024-01292
    Event Type
    Malfunction
    Date Received
    January 6, 2025
    Date of Event
    November 1, 2024
    Report Date
    January 21, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057580
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO PHYSICAL SAMPLE WAS RETURNED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. 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.

    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

    MATERIAL: 305758 BATCH#: 3142041 IT WAS REPORTED BY THE CUSTOMER THAT FOREIGN PARTICULATE MATTER WITH THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PCI PO #564938 BD ITEM #305758 ¿ 27G X ½¿ ECLIPSE NEEDLE BD LOT #3142041 ISSUE: PCI RECEIVED A CUSTOMER COMPLAINT REPORTING FOREIGN PARTICULATE MATTER WITH THE NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 27X1/2 HAD FOREIGN MATTER IT WAS REPORTED BY THE CUSTOMER THAT FOREIGN PARTICULATE MATTER WITH THE NEEDLE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PCI PO (B)(4). BD ITEM #305758 ¿ 27G X ½¿ ECLIPSE NEEDLE BD. LOT #3142041 ISSUE: PCI RECEIVED A CUSTOMER COMPLAINT REPORTING FOREIGN PARTICULATE MATTER WITH THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1137782 BD NEEDLE ECLIPSE 27X1/2 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 3142041 00382903057580

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown