BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 22019837 · Received May 14, 2025

    Report

    Report Number
    1911916-2025-00343
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    April 30, 2025
    Report Date
    May 23, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE ARE SYRINGES WITH PARTICULATE INSIDE THE STERILE CONTAINER. TO SUPPORT THE INVESTIGATION, TWO SEALED BLISTER-PACKAGED SAMPLES AND FOUR PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. THE SAMPLES CORRESPOND TO LOT NUMBERS 5059088 AND 5050897. A VISUAL INSPECTION WAS CONDUCTED BY TWO DIFFERENT ASSOCIATES USING 10X AND 30X MAGNIFICATION. NO DEFECTS, IMPERFECTIONS, OR FOREIGN MATERIALS WERE OBSERVED IN EITHER SAMPLE. AMONG THE FOUR SUBMITTED PHOTOGRAPHS, TWO DEPICT THE TOP WEBS OF THE BLISTER PACKAGING, WHILE THE REMAINING TWO SHOW A SYRINGE WITH WHAT APPEARS TO BE A PARTICLE ADHERED TO THE RUBBER STOPPER. NO ADDITIONAL ANOMALIES WERE IDENTIFIED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 309653, COVERING BOTH LOT 5059088 AND LOT 5050897. THE REVIEW FOUND NO QUALITY ISSUES DURING PRODUCTION THAT COULD BE LINKED TO THE REPORTED CONDITION. ADDITIONALLY, THERE WERE NO ASSOCIATED QUALITY NOTIFICATIONS. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION, INCLUDING PHOTOGRAPHIC EVIDENCE, THE PRESENCE OF THE REPORTED PARTICLE HAS BEEN CONFIRMED.

    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.

    Description of Event or Problem · 0

    MATERIAL#: 309653, BATCH#: 5059088, 5050897. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE TWO 50 ML SYRINGE WITH SMALL PLASTIC PIECES SEALED INSIDE OF THE PACKAGE. VERBATIM: TODAY I HAVE ENCOUNTERED TWO ADDITIONAL 50 ML SYRINGES WITH PARTICULATE INSIDE THE STERILE CONTAINER. I HAVE ATTACHED PHOTOS TO DEMONSTRATE WHAT I AM FINDING, WHICH IS NEARLY IDENTICAL TO THE TWO SYRINGES I SENT TO YOU FOR WHICH YOU COULD NOT FIND PARTICULATE. THESE SYRINGES ARE FROM TWO SEPARATE LOT NUMBERS, DIFFERENT LOTS THAN THE SYRINGES REPORTED IN THE CLOSURE LETTER ATTACHED. ADDITIONAL INFORMATION NO PATIENT HARM EVENTS HAVE BEEN REPORTED TO ME, BUT THAT WOULD BE VERY DIFFICULT TO TRACE BACK TO A SYRINGE SO THE HARM IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1749984 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 5050897 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown