BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 22807123 · Received August 14, 2025

    Report

    Report Number
    1911916-2025-00577
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    August 7, 2025
    Report Date
    August 19, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096534
    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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A REPORT WAS RECEIVED INDICATING THAT SOME PLUNGERS EXHIBITED AN EXCESSIVE OILY SUBSTANCE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE IN AN OPENED BLISTER PACKAGE AND SIX PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED SAMPLE. THE SYRINGE'S RUBBER STOPPER SHOWED SIGNS OF LUBRICANT OVERFLOW. THE SIX ACCOMPANYING PHOTOGRAPHS CORROBORATED THE CONDITION OBSERVED IN THE SAMPLE. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE NOTED. THIS CONDITION IS CONSISTENT WITH POTENTIAL DROOLING FROM THE LUBRICANT NOZZLE DURING APPLICATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED FOR MATERIAL NUMBER 309653, LOT 5142409. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE LUBRICANT APPLICATION PROCESS CONFIRMED THAT THE EQUIPMENT SETTINGS WERE WITHIN SPECIFICATION AND THE NOZZLE WAS FUNCTIONING PROPERLY. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CONDITION REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, 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 EXCESSIVE OILY SUBSTANCE. EVENT DESCRIPTION: MATERIAL # 309653 BATCH # 5142409 I¿M FOLLOWING UP REGARDING A PREVIOUSLY REPORTED CONCERN ABOUT STICKY PLUNGERS IN STERILE SYRINGES. UNFORTUNATELY, THIS ISSUE HAS REOCCURRED AND APPEARS TO AFFECT MULTIPLE SYRINGE SIZES, INCLUDING 10 ML AND 50 ML. WE¿VE OBSERVED THAT SOME PLUNGERS HAVE AN EXCESSIVE OILY SUBSTANCE ON THEM, WHICH COMPROMISES THEIR STERILITY AND USABILITY. WHILE MOST SYRINGES IN A BOX MAY APPEAR NORMAL, OCCASIONALLY ONE WILL BE AFFECTED¿THIS INCONSISTENCY IS PARTICULARLY TROUBLING IN OUR PRACTICE, WHERE EVEN A SINGLE COMPROMISED SYRINGE POSES A SERIOUS RISK. WE ARE UNSURE OF THE SPECIFICS OF YOUR QUALITY ASSURANCE PROGRAM, OR THE TYPE OF LUBRICANT USED (IF ANY) ON THE PLUNGERS. HOWEVER, BASED ON OUR OBSERVATIONS, IT SEEMS THAT SOME SYRINGES MAY EXCEED ACCEPTABLE LIMITS FOR RESIDUAL LUBRICANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782465 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 5142409 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown