BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 21458767 · Received February 25, 2025

    Report

    Report Number
    9614033-2025-00010
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: TWO SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLES DID NOT SHOW ANY DEFECTS; THEREFORE, THE INCIDENT COULD NOT BE VERIFIED. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    MATERIAL#: 304657, BATCH#: 4193532. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER(S): (B)(4). PRODUCT SKU: 304657, 301073. PRODUCT LOT NUMBER: 4193532. COMPLAINT DETAILS: SYRINGES LEAKING. ADDITIONAL INFORMATION PROVIDED: 1. PLEASE PROVIDE THE DATE OF EVENT FOR MATERIAL#: 304657 & 301073, CUSTOMER DID NOT PROVIDE EVENT DATE, BUT ISSUE WAS REPORTED TO MEDLINE 12/31/2024. 2. PLEASE PROVIDE THE BATCH# OR LOT# NUMBER FOR 301073? UNKNOWN. 3. PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? ATTN: (B)(6) 4. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT, NONE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037682 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4193532

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown