BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13 MM SS VIAL ACCESS DEVICE

    MDR report key: 20881007 · Received December 9, 2024

    Report

    Report Number
    9616066-2024-01969
    Event Type
    Malfunction
    Date Received
    December 9, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 5, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    LHI
    UDI-DI
    07613203011792
    PMA / PMN Number
    K233021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. NO PRODUCT WILL BE RETURNED PER CUSTOMER. NO INVESTIGATION WAS PERFORMED.

    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

    MATERIAL#: 2203E. BATCH NUMBER#: 23125149. IT WAS REPORTED BY CUSTOMER THAT VIAL ADAPTOR LEAKING DURING USE. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. COVE ID (B)(4). DATE OF COMPANY AWARENESS 10/07/2024. MERCK FG BATCH # Y007209. BD VIAL ADAPTER BATCH 23125149. PQC CATEGORY VIAL ADAPTOR LEAKING DURING USE.

    Description of Event or Problem · 0

    MATERIAL#: 2203E, BATCH NUMBER#: 23125149. IT WAS REPORTED BY CUSTOMER THAT VIAL ADAPTOR LEAKING DURING USE. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. COVE ID COMPLAINT - (B)(4). DATE OF COMPANY AWARENESS: 10/07/2024. MERCK FG BATCH # Y007209. BD VIAL ADAPTER BATCH 23125149. PQC CATEGORY VIAL ADAPTOR LEAKING DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2503075 13 MM SS VIAL ACCESS DEVICE SET, I.V. FLUID TRANSFER LHI BECTON DICKINSON 23125149 07613203011792

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown