BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18517168 · Received January 16, 2024

    Report

    Report Number
    18517168
    Event Type
    Malfunction
    Date Received
    January 16, 2024
    Date of Event
    October 19, 2023
    Report Date
    November 3, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    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 305180, LOT 3181345. MANUFACTURER RESPONSE FOR SYRINGE, PLASTIPAK 3ML SYRINGE (PER SITE REPORTER) [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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872914 BD LUER-LOK SYRINGE, PISTON FMF BECTON, DICKINSON AND COMPANY 309657 3173752

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown