BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 22800381 · Received August 13, 2025

    Report

    Report Number
    1911916-2025-00573
    Event Type
    Malfunction
    Date Received
    August 13, 2025
    Date of Event
    August 5, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. A SYRINGE WAS REPORTED TO EXHIBIT VISIBLE SIGNS OF CONTAMINATION, DESCRIBED AS DIRT-LIKE SPECKS ACROSS ITS SURFACE. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. HOWEVER, TWO PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY THE QUALITY TEAM TO SUPPORT THE INVESTIGATION. THE IMAGES DEPICT A SYRINGE WITH DARK-COLORED SPECKS EXTENDING FROM THE BARREL FLANGE TO THE LUER LOCK. BASED ON THEIR APPEARANCE AND LOCATION, THESE SPECKS ARE CONSISTENT WITH EMBEDDED DEGRADED RESIN. NO ADDITIONAL DEFECTS OR ANOMALIES WERE OBSERVED. THE PRESENCE OF DEGRADED RESIN IS TYPICALLY ASSOCIATED WITH STARTUP CONDITIONS OR INTERMITTENT OCCURRENCES DURING THE INJECTION MOLDING PROCESS, WHERE DEGRADED MATERIAL MAY DISLODGE AND BECOME INCORPORATED INTO MOLDED COMPONENTS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 302832, LOT 5120125. THE 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 COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE PHOTOGRAPHIC EVIDENCE AND INVESTIGATION FINDINGS, THE REPORTED CONDITION HAS BEEN CONFIRMED.

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

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: MATERIAL#: 9870358; BATCH#: 5120125. THE SYRINGE HAS VISUAL SIGNS OF DIRT ALL OVER THE SYRINGE. FOUND 1 SYRINGE IN THIS LOT AS OF NOW. I STILL HAVE4 BOXES UNOPENED ON HAND USING IT AS ALL MIGHT BE CONTAMINATED I CAN SEND THE PICTURES OF THE DIRTY SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829653 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 5120125 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown