BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 20ML LUER LOK SYRINGE

    MDR report key: 17674793 · Received September 2, 2023

    Report

    Report Number
    9614033-2023-00091
    Event Type
    Malfunction
    Date Received
    September 2, 2023
    Date of Event
    August 19, 2023
    Report Date
    January 23, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FIVE SYRINGE SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION, TWO FROM BATCH 3012134, TWO FROM BATCH 3012159, AND ONE FROM BATCH 3012139. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITH WHAT APPEARS TO BE SILICONE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3012139,3012159,3012144,3012134, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR THE SAMPLES SENT AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE INVESTIGATION RESULTS, NO MANUFACTURING RELATED DEFECTS COULD BE IDENTIFIED, THE SILICONE NOTICED BY CUSTOMER MAY BE DUE TO A BAD DISTRIBUTION OF THE MATERIAL INSIDE THE BARREL. SILICONE TANK CLEANING AND DOSING VALVE WILL BE UPDATED.

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 3012144 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2028 H.4. DEVICE MANUFACTURE DATE: 15-MAR-2023 D.4. MEDICAL DEVICE LOT #: 3012159 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2028 H.4. DEVICE MANUFACTURE DATE: 31-MAR-2023 D.4. MEDICAL DEVICE LOT #: 3012134 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2028 H.4. DEVICE MANUFACTURE DATE: 03-MAR-2023 D.4. MEDICAL DEVICE LOT #: 3012139 D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2028 H.4. DEVICE MANUFACTURE DATE: 08-MAR-2023 H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 20ML LUER LOK SYRINGE EXPERIENCED MOISTURE IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE EXPERIENCED AN ISSUE WITH THE 20ML AND 10ML SYRINGES IN OUR ORGANIZATION. THERE IS MOISTURE IN THE SYRINGE THAT IS NOTICEABLE ONLY ONCE IT IS OPENED. WE HAVE SEQUESTERED THE LOTS BELOW WITHIN OUR ORGANIZATION TO PREVENT PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2250041 BD 20ML LUER LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3012139 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown