BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 22395000 · Received July 3, 2025

    Report

    Report Number
    1911916-2025-00480
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 -A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP FOR DEVICE EVALUATION: A REPORT WAS RECEIVED INDICATING POTENTIAL CONTAMINATION WITHIN A SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE IN SEALED BLISTER PACKAGING WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. UPON VISUAL INSPECTION, A BROWN-COLORED SPECK WAS OBSERVED EMBEDDED WITHIN THE SYRINGE BARREL. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE IDENTIFIED. THE EMBEDDED DEGRADED RESIN IS A CONDITION THAT CAN OCCUR DURING THE STARTUP PHASE OR INTERMITTENTLY THROUGHOUT THE INJECTION MOLDING PROCESS. THIS MATERIAL MAY DISLODGE AND BECOME INCORPORATED INTO MOLDED COMPONENTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR MATERIAL NUMBER 309653, LOT 5120229. THE REVIEW FOUND NO QUALITY ISSUES OR DEVIATIONS DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE USED FOR INTERNAL AWARENESS. TO DATE, NO OTHER SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER-REPORTED ISSUE HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    DESCRIPTION: IT WAS REPORTED HAS CONTAMINATION IN THE SYRINGE AND BARREL. VERBATIM: CUSTOMER STATES THAT ITEM 309653 LOT 5120229 HAS CONTAMINATION IN THE SYRINGE AND BARRELL. IT WAS NOT USED ON A PATIENT. CUSTOMER HAS PRODUCT TO RETURN IF NEEDED. OCCURRENCES: (B)(4). OCCURENCE DATE: (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1176094 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 5120229 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown