BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X5/8

    MDR report key: 20371077 · Received October 4, 2024

    Report

    Report Number
    2243072-2024-01015
    Event Type
    Malfunction
    Date Received
    October 4, 2024
    Date of Event
    September 6, 2024
    Report Date
    October 21, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057597
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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

    OUR QUALITY ENGINEER INSPECTED THE 200 REPRESENTATIVE SAMPLES SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF SAFETY MECHANISM FAILURE WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. ANALYSIS OF THE SAMPLES SHOWED NO DAMAGES OR DEFECTS. 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 LOT MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. THE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEFECT WAS NOT REPLICATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SAFETY MECHANISM FAILED. IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE OF THEM TO BE POKED VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: 305759.. QUANTITY AFFECTED: 5 BX. LOT NUMBER: 4023388. PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: WE ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE OF THEM TO BE POKED. CUSTOMER DISPOSITION REQUEST: CREDIT. CUSTOMER CONTACT INFORMATION: XXXX.

    Description of Event or Problem · 0

    MATERIAL # 305759; BATCH # 4023388. IT WAS REPORTED BY CUSTOMER THAT THEY ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE OF THEM TO BE POKED VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ITEM: 305759; QUANTITY AFFECTED: (B)(4); SERIAL/LOT NUMBER: (B)(6); PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: WE ARE HAVING SOME SAFETY ISSUES WITH OUR BD NEEDLES. ON MULTIPLE OCCASIONS THE PINK SAFETY SHIELD HAS POPPED OFF AND ALSO WHEN WE ARE SCREWING IT ON TO THE VIALS SOMETIMES IT BREAKS OFF. THIS HAPPENED TO ME PERSONALLY BEFORE AND YESTERDAY IT HAPPENED TO ONE OF OUR OTHER LVNS WHO ACTUALLY HAD A NEEDLE STICK INCIDENT. THIS IS REALLY DANGEROUS WORKING WITH OUR PEDIATRIC PATIENTS BECAUSE SOMETIMES THEY HAVE FAST HANDS TOO AND I WOULD HATE FOR ONE OF THEM TO BE POKED. CUSTOMER DISPOSITION REQUEST: CREDIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1443122 BD NEEDLE ECLIPSE 25X5/8 HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 4023388 00382903057597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown