BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BN

    MDR report key: 24088330 · Received January 15, 2026

    Report

    Report Number
    9614033-2026-00003
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    October 2, 2025
    Report Date
    February 23, 2026
    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: THE CLAIM IS CLASSIFIED AS UNCONFIRMED, SINCE THERE ARE NO PHYSICAL SAMPLES OR PHOTOGRAPHIC EVIDENCE TO VERIFY THE CONDITION OF THE SYRINGE. IT IS IMPORTANT TO MENTION THAT NO QUALITY EVENTS RELATED TO THE REPORTED DEFECT WERE FOUND IN THE BATCH RECORD DURING THE PRODUCT¿S MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. 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

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS BARREL / FLANGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 304657 BATCH # 4193528. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED COMPONENT NO (B)(4). COMPLAINT NUMBER(S): (B)(4). PRODUCT SKU: COMPONENT NO (B)(4) (DNOSYR 3ML L/L). COMPONENT NO (B)(4) (DNOSYRINGE 10ML LL BNS) COMPONENT NO (B)(4) (DNQSYRINGE 5ML LL BNS) PRODUCT LOT NUMBER: UNKNOWN (DNOSYR 3ML L/L), 4193528 (DNOSYRINGE 10ML LL BNS), 4193540 (DNQSYRINGE 5ML LL BNS). COMPLAINT DETAILS: ¿ACCORDING TO THE FACILITY, ON (B)(6)2025, DURING A PROCEDURE, IT WAS NOTICED THAT THE SYRINGE HAD HOLES IN IT CAUSING MEDICATION TO LEAK IN THE TRAY. PER THE FACILITY, THERE WAS NO PATIENT INVOLVEMENT OR INJURY RELATED TO THE INCIDENT. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. NO ADDITIONAL INFORMATION AT THIS TIME. TO DATE, NO INFORMATION HAS BEEN RECEIVED TO INDICATE THAT A USER OR A PATIENT EXPERIENCED A DEATH, SERIOUS INJURY, MEDICAL INTERVENTION, FOLLOW-UP CARE, OR OTHER ADVERSE HEALTH IMPACT ASSOCIATED WITH THE REPORTED PROBLEM/ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494980 BD SYRINGE 10ML LL BN PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4193528

    Patients

    Seq Age Sex Outcome Treatment
    1