BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 18X1-1/2 RB

    MDR report key: 18194098 · Received November 22, 2023

    Report

    Report Number
    2243072-2023-02084
    Event Type
    Malfunction
    Date Received
    November 22, 2023
    Date of Event
    October 27, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903057666
    PMA / PMN Number
    K010188
    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    BASED ON DEVICE HISTORY RECORD REVIEW, NO ABNORMALITY WAS OBSERVED DURING THE PRODUCTION OF THE AFFECTED BATCHES. CURRENT CONTROL THERE IS A VISUAL INSPECTION ON FM AT THE QA OUTGOING INSPECTION PER MQA-052/A AND VISUAL INSPECTION ON FM AT THE PRIMARY PACKAGING IN-PROCESS INSPECTION PER MFG-043/K. ACTUAL ROOT CAUSE COULD NOT BE DETERMINED AS ACTUAL SAMPLE WAS NOT RECEIVED FOR INVESTIGATION. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED WHEN SAMPLE IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 18X1-1/2 RB HAS FOREIGN MATTER MATERIAL: 305766 BATCH#: 227661(THIS LOT PROVIDED AS UNKNOWN) AND 2336576 IT WAS REPORTED BY CUSTOMER THAT A QCH CLINICAL TEAM, THE PHARMACY DEPT, HAS RECENTLY HAD AN ISSUE WITH BD # NEEDLE 18G 1 1/2" 305766 SAFE. THE LOTS ARE 227661 EXP 2027-09-30 & 2336576 EXP 2027-11-30. THIS IS THE CONCERN, NEEDLES ARE CAUSING CORING IN VIALS FOR MULTIPLE PRODUCTS. UNABLE TO USE IV PRODUCTS WITH PARTICLES & CORING PIECES IN THE VIAL. VERBATIM: "A QCH CLINICAL TEAM, THE PHARMACY DEPT, HAS RECENTLY HAD AN ISSUE WITH BD # NEEDLE 18G 1 1/2" 305766 SAFE. THE LOTS ARE 227661 EXP 2027-09-30 & 2336576 EXP 2027-11-30. THIS IS THE CONCERN, NEEDLES ARE CAUSING CORING IN VIALS FOR MULTIPLE PRODUCTS. UNABLE TO USE IV PRODUCTS WITH PARTICLES & CORING PIECES IN THE VIAL."

    Description of Event or Problem · 0

    MATERIAL: 305766 BATCH#: 227661(THIS LOT PROVIDED AS UNKNOWN) AND 2336576. IT WAS REPORTED BY CUSTOMER THAT A QCH CLINICAL TEAM, THE PHARMACY DEPT, HAS RECENTLY HAD AN ISSUE WITH BD # NEEDLE 18G 1 1/2" 305766 SAFE. THE LOTS ARE 227661 EXP 2027-09-30 & 2336576 EXP 2027-11-30. THIS IS THE CONCERN, NEEDLES ARE CAUSING CORING IN VIALS FOR MULTIPLE PRODUCTS. UNABLE TO USE IV PRODUCTS WITH PARTICLES & CORING PIECES IN THE VIAL. VERBATIM: "A QCH CLINICAL TEAM, THE PHARMACY DEPT, HAS RECENTLY HAD AN ISSUE WITH BD # NEEDLE 18G 1 1/2" 305766 SAFE. THE LOTS ARE 227661 EXP 2027-09-30 & 2336576 EXP 2027-11-30. THIS IS THE CONCERN, NEEDLES ARE CAUSING CORING IN VIALS FOR MULTIPLE PRODUCTS. UNABLE TO USE IV PRODUCTS WITH PARTICLES & CORING PIECES IN THE VIAL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989210 BD NEEDLE ECLIPSE 18X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 30382903057666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown