BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 19237622 · Received May 3, 2024

    Report

    Report Number
    1911916-2024-00304
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 29, 2024
    Report Date
    May 17, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    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 WERE VARIOUS BROWN DISCOLORATION SPOTS ON THE PLUNGER. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND THE SYRINGE BARREL HAS BROWN SPECKS OF EMBEDDED DEGRADED RESIN. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. 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 4058952. 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 SAMPLES WILL BE SHOWN TO 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

    MATERIAL # 309653, LOT # 4058952. IT WAS REPORTED BY CUSTOMER THAT ONE BD 50ML SYRINGE WITH VARIOUS BROWN DISCOLORATION SPOTS ON THE PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GREETINGS, THIS EMAIL IS TO REPORT ONE BD 50ML SYRINGE WITH VARIOUS BROWN DISCOLORATION SPOTS ON THE PLUNGER. LOT 4058952, 2029-02-28. THE CARTON HAS BEEN EXAMINED, AND THERE WAS ONLY ONE SUCH IMPACTED SYRINGE IN THE CARTON. THE SYRINGE ISSUE WAS DISCOVERED ON 4/29/2024. IT WAS NOT USED FOR PATIENT CARE OR ANY OTHER PURPOSE AND HAS BEEN SEQUESTERED. PLEASE ADVISE IF RETURN TO BD IS REQUESTED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED MATERIAL # 309653 LOT # 4058952 IT WAS REPORTED BY CUSTOMER THAT ONE BD 50ML SYRINGE WITH VARIOUS BROWN DISCOLORATION SPOTS ON THE PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. GREETINGS, THIS EMAIL IS TO REPORT ONE BD 50ML SYRINGE WITH VARIOUS BROWN DISCOLORATION SPOTS ON THE PLUNGER (SEE ATTACHED PHOTO). LOT 4058952 2029-02-28 THE CARTON HAS BEEN EXAMINED, AND THERE WAS ONLY ONE SUCH IMPACTED SYRINGE IN THE CARTON. THE SYRINGE ISSUE WAS DISCOVERED ON (B)(6) 2024. IT WAS NOT USED FOR PATIENT CARE OR ANY OTHER PURPOSE AND HAS BEEN SEQUESTERED. PLEASE ADVISE IF RETURN TO BD IS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493249 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4058952 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown