BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL S/C 48

    MDR report key: 21881395 · Received April 22, 2025

    Report

    Report Number
    1911916-2025-00294
    Event Type
    Malfunction
    Date Received
    April 22, 2025
    Date of Event
    April 4, 2025
    Report Date
    April 23, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THAT THE SEAL WIDTH DOES NOT MEET SPECIFICATIONS. TO SUPPORT THE INVESTIGATION, SIXTEEN PACKAGING BLISTER SAMPLES AND FOUR PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED, REVEALING THAT FIVE SAMPLES EXHIBITED AN OPENING BETWEEN THE TOP AND BOTTOM WEBS OF THE PACKAGING. ONE PHOTOGRAPH DEPICTED A PACKAGING LABEL, WHILE THE REMAINING PHOTOGRAPHS SHOWED PACKAGING BLISTERS, WITH ONE BLISTER DISPLAYING AN OPENING ON ONE SIDE. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION MAY OCCUR IF THE SEAL GASKET IS NOT PROPERLY CENTERED DURING THE PACKAGING SEALING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 302830, LOT 5031468. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLES WILL BE SHARED WITH ASSOCIATES FOR AWARENESS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER'S REPORTED SYMPTOM IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL#: 302830, BATCH#: 5031468. IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND THAT 50% OF THE #302030 WERE NOT SEALED, OR THE SEAL WIDTH WAS UNDER 1/8TH. RCC RECEIVED A COMPLAINT VIA EMAIL. DURING OUR DV PRE-INSPECTION, WE FOUND THAT 50% OF THE #: 302030 WERE NOT SEALED, OR THE SEAL WIDTH WAS UNDER 1/8TH. BASED ON OUR INSPECTION CRITERIA WE REJECTED THESE FROM OUR TEST SAMPLES. THESE WERE FOUND DURING THE PRE-INSPECTION PERFORMED BEFORE TESTING, RIGHT OUT OF THE BOX. WE BELIEVE THAT IT IS A MANUFACTURING DEFECT AS THE SEAL WIDTH IS NOT TO SPECIFICATION. IT APPEARS THAT DURING THE SLITTING PROCESS, THERE IS SIGNIFICANT LATERAL FLOAT; THEREFORE, WITH THE DESIGNED MINIMUM SEAL WIDTH AND CAVITY, THE SLITS BECOME OFF-CENTERED, RESULTING IN NARROWER SEALS AND OFTEN NO SEAL AT ALL.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261000 SYRINGE 20ML LL S/C 48 SYRINGE, PISTON FMF BECTON DICKINSON 5031468 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown