BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL BNS

    MDR report key: 21458768 · Received February 25, 2025

    Report

    Report Number
    1213809-2025-00131
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 5, 2025
    Report Date
    March 29, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010733
    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

    (B)(4) - SUPPLEMENTAL MDR - LEAKAGE OTHER FOUR SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES WERE TESTED FOR LEAKAGE PAST STOPPER AND LEAKAGE AT LUER CONNECTION. THE REPORTED DEFECT WAS NOT OBSERVED IN THE SAMPLES RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    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 WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL #:301073. BATCH#:UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 3ML LL BNS HAD LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER(S): (B)(4). PRODUCT SKU: (B)(4). 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? MEDLINE INDUSTRIES, LP. 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
    1037683 BD SYRINGE 3ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 50382903010733

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown