BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 22347021 · Received June 27, 2025

    Report

    Report Number
    1911916-2025-00446
    Event Type
    Malfunction
    Date Received
    June 27, 2025
    Date of Event
    June 16, 2025
    Report Date
    July 11, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903028306
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP. A REPORT WAS RECEIVED INDICATING THE PRESENCE OF FOREIGN MATTER AT THE TIP OF A SYRINGE. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY OUR QUALITY TEAM. THE IMAGES DEPICT DARK-COLORED SPECKS LOCATED AT THE BOTTOM OF THE SYRINGE BARREL, WITH ONE IMAGE ALSO SHOWING THE TOP WEB OF THE BLISTER PACKAGING. BASED ON THE PHOTOGRAPHS ALONE, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE SPECKS ARE EMBEDDED. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED FOR MATERIAL NUMBER 302830, LOT 4122288. THE REVIEW FOUND NO QUALITY ISSUES OR DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD BE LINKED TO THE REPORTED CONDITION. ADDITIONALLY, THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE REPORTED CONDITION HAS BEEN CONFIRMED. HOWEVER, IN THE ABSENCE OF THE PHYSICAL SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE.

    Description of Event or Problem · 0

    EVENT DETAILS: FOREIGN MATTER AT THE TIP OF SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002962 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 4122288 00382903028306

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown