BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 19773084 · Received July 18, 2024

    Report

    Report Number
    1911916-2024-00522
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    July 7, 2021
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP MDR FOR CORRECTION. FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS PR IS A DUPLICATE OF (B)(4). THIS MDR WILL BE VOIDED.

    Additional Manufacturer Narrative · 0

    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

    DUPLICATE OF (B)(4).

    Description of Event or Problem · 0

    MATERIAL # 301033. BATCH # 0100616. IT WAS REPORTED BY CUSTOMER THAT SYRINGE MISSING NUMBERS DAMAGED TIP. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NOTIFICATION NUMBER (B)(4). NOTIFICATION CREATED DATE 3/16/2022. NOTIFICATION DESCRIPTION SYRINGE MISSING NUMBERS DAMAGED TIP. COMPONENT NUMBER 33239. COMPONENT DESCRIPTION LTS 20 ML LUER-LOK SYRINGE. COMPONENT LOT SERIAL NUMBER (B)(6). REGULATORY DATE REPORTED 3/19/2024. REGULATORY REFERENCE NUMBER 1423395-2024-00150.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1556540 SYRINGE 30ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 0100616

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown