BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 18554645 · Received January 22, 2024

    Report

    Report Number
    1911916-2024-00031
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    October 19, 2023
    Report Date
    February 12, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS COMPLAINT IS A DUPLICATE OF (B)(4) AND IS BEING CANCELLED IN OUR SYSTEM. AN MDR FOR (B)(4) HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    (B)(4): INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    FOLLOW UP WITH CUSTOME INDICATED THAT THIS IS A DUPLICATE TO (B)(4).

    Description of Event or Problem · 0

    MATERIALS#: 305180, BATCH#: 3181345. IT WAS REPORTED BY THE CUSTOMER THAT NOTICED WHAT APPEARED TO BE A CLEAR, FOREIGN OBJECT IN THE SYRINGE. (SITE IS NOT SURE IF DEBRIS WAS IN THE SYRINGE OR IN THE NEEDLE AND BROUGHT INTO THE SYRINGE UPON PULLING BACK). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. UPON ASSEMBLY OF NEEDLE AND SYRINGE THE USER NOTICED WHAT APPEARED TO BE A CLEAR, FOREIGN OBJECT IN THE SYRINGE. IT LOOKED LIKE GLASS AND UPON REMOVAL OF THE PLUNGER THERE WAS A HARD, CLEAR SUBSTANCE ON THE PLUNGER. NOTHING HAD BEEN DRAWN INTO THE SYRINGE AT THIS TIME AND BOTH WERE UNUSED AT THIS TIME. [REDACTED DATE] - EMAIL SENT TO BD REQUESTING RMA. [REDACTED DATE] - BD EMAIL ACKNOWLEDGMENT OF COMPLAINT RECEIVED. BD COMPLAINT (B)(4). RMA RECEIVED; SAMPLE SHIPPED FED-EX. (SITE IS NOT SURE IF DEBRIS WAS IN THE SYRINGE OR IN THE NEEDLE AND BROUGHT INTO THE SYRINGE UPON PULLING BACK). NEEDLE ALSO SENT: BD BLUNT FILL NEEDLE 18G, REF (B)(4), LOT 3181345.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511364 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 3181345 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown