BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 20ML LL S/C 48

    MDR report key: 23221636 · Received October 6, 2025

    Report

    Report Number
    1911916-2025-00668
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 15, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4), FOLLOW UP: BLACK MARKS WERE REPORTED TO APPEAR WHEN THE SYRINGE STOPPER IS PULLED BACK. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. THE IMAGE DEPICTS THE LOWER PORTION OF TWO SYRINGES CONTAINING A WHITE SOLUTION. VISIBLE ON THE SYRINGE BARRELS ARE DARK INK RINGS, WHICH ARE ATTRIBUTED TO THE SYRINGE BARREL SCALE PRINTING PROCESS. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. THIS CONDITION CAN OCCUR WHEN A JAM DURING THE PRINTING PROCESS CAUSES MISALIGNMENT OF THE DOCTOR BLADE. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER (B)(4), LOT 5101212. THE REVIEW FOUND NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION, AND NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE SYRINGE BARREL SCALE PRINTING PROCESS CONFIRMED THAT SETTINGS, ADJUSTMENTS, AND ALIGNMENT WERE WITHIN ACCEPTABLE PARAMETERS, AND PRODUCT FLOW WAS CONSISTENT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE SUBMITTED PHOTOGRAPH, THE REPORTED SYMPTOM HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 20ML LL S/C 48 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302830 BATCH # 5101212. RCC RECEIVED A COMPLAINT VIA PHONE. INSIDE PLASTIC SYRINGE BLACK MARKS APPEARING WHEN STOPPER IS PULLED BACK SYRINGE DISCARDED. PRODUCT CODE 3699780945 LOT # 5101212.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2342469 BD SYRINGE 20ML LL S/C 48 PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5101212

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown