BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 30ML LL BNS

    MDR report key: 23393209 · Received October 27, 2025

    Report

    Report Number
    1911916-2025-00698
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Date of Event
    September 29, 2025
    Report Date
    November 5, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    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

    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 FOR DEVICE EVALUATION IT WAS REPORTED THERE WAS FOREIGN OBJECT ON THE SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING AND TWO PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL FLANGE HAS EMBEDDED DEGRADED RESIN. THE IMAGES DEPICT THE UPPER PORTION OF THE SYRINGE. THE BARREL FLANGE SHOWS A DISCOLORATION CONSISTENT WITH EMBEDDED DEGRADED RESIN. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. THE PRESENCE OF DEGRADED RESIN IS TYPICALLY ASSOCIATED WITH STARTUP CONDITIONS OR INTERMITTENT OCCURRENCES DURING THE INJECTION MOLDING PROCESS. DURING THESE TIMES, RESIN DEGRADATION CAN RESULT IN FRAGMENTS THAT BECOME INCORPORATED INTO MOLDED COMPONENTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 302033, LOT 4172667. THIS REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE REPORTED CONDITION HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP IT WAS REPORTED THERE WAS FOREIGN OBJECT ON THE SYRINGE. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM. THESE IMAGES DEPICT THE UPPER PORTION OF THE SYRINGE. THE BARREL FLANGE SHOWS A DISCOLORATION CONSISTENT WITH EMBEDDED DEGRADED RESIN. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. THE PRESENCE OF DEGRADED RESIN IS TYPICALLY ASSOCIATED WITH STARTUP CONDITIONS OR INTERMITTENT OCCURRENCES DURING THE INJECTION MOLDING PROCESS. DURING THESE TIMES, RESIN DEGRADATION CAN RESULT IN FRAGMENTS THAT BECOME INCORPORATED INTO MOLDED COMPONENTS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 302033, LOT 4172667. THIS REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE REPORTED CONDITION HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 30ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 301033 BATCH # 4172667. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. THERE WAS A FOREIGN OBJECT ON THE SYRINGE. PRODUCT NUMBER - 301033.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2428019 BD SYRINGE 30ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 4172667

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown