BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19739590 · Received July 15, 2024

    Report

    Report Number
    1911916-2024-00499
    Event Type
    Malfunction
    Date Received
    July 15, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 25, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A RESIDUE ON THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL FLANGE HAS EMBEDDED DEGRADED RESIN. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4151253. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO THE ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIALS#: 309653, BATCH#: 4151253. IT WAS REPORTED BY THE CUSTOMER THAT 50 ML BD SYRINGE WAS OPENED FROM PACKAGING AND THERE IS BROWN/BLACK RESIDUE NOTED ON/IN SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. 50 ML BD SYRINGE WAS OPENED FROM PACKAGING AND THERE IS BROWN/BLACK RESIDUE NOTED ON/IN SYRINGE. THE LOT# ON THE PACKAGING IS 4151253. NOT EXPIRED (EXPIRY 2029-05-31). PRODUCT#: BD309653.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIALS#: 309653. BATCH#: 4151253. IT WAS REPORTED BY THE CUSTOMER THAT 50 ML BD SYRINGE WAS OPENED FROM PACKAGING AND THERE IS BROWN/BLACK RESIDUE NOTED ON/IN SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. 50 ML BD SYRINGE WAS OPENED FROM PACKAGING AND THERE IS BROWN/BLACK RESIDUE NOTED ON/IN SYRINGE. ¿THE LOT# ON THE PACKAGING IS 4151253. NOT EXPIRED (EXPIRY 2029-05-31). PRODUCT#: BD309653.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285913 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4151253

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown