BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 22159033 · Received June 6, 2025

    Report

    Report Number
    1911916-2025-00395
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 14, 2025
    Report Date
    July 11, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED THE RUBBER STOPPER OF ONE SYRINGE DID NOT HAVE A GOOD SEAL. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 309653 AND LOT NUMBER 3110742. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A REPORT WAS RECEIVED INDICATING THAT THE RUBBER STOPPER ON ONE SYRINGE DID NOT MAINTAIN AN ADEQUATE SEAL. TO SUPPORT THE INVESTIGATION, TWO SAMPLES IN OPENED BLISTER PACKAGING WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION OF THE SAMPLES REVEALED NO OBSERVABLE DEFECTS OR IMPERFECTIONS. BOTH SAMPLES SUBSEQUENTLY UNDERWENT LEAK TESTING AND PASSED ALL CRITERIA. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR MATERIAL NUMBER 309653, LOT 3110742, WAS CONDUCTED. THE REVIEW FOUND NO QUALITY ISSUES OR DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE REPORTED ISSUE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    NO NEGATIVE OUTCOME.

    Description of Event or Problem · 0

    MATERIAL # 309653. BATCH # 3110742. IT WAS REPORTED BY CUSTOMER THAT THE RUBBER STOPPER OF ONE OF THE SYRINGES¿ PLUNGERS DID NOT HAVE A GOOD SEAL. VERBATIM: (B)(4) RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE ORDERED FROM YOU 50ML SYRINGES, CAT. # 309653, LOT # 3110742. WE WANTED TO LET YOU KNOW THAT THE RUBBER STOPPER OF ONE OF THE SYRINGES¿ PLUNGERS DID NOT HAVE A GOOD SEAL. SO, WHILE WE WERE USING THAT SYRINGE, THE PRODUCT LEAKED FROM THE TOP OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719728 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 3110742 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown