BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER LOK SYRINGE

    MDR report key: 17131126 · Received June 14, 2023

    Report

    Report Number
    3003152976-2023-00231
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 23, 2023
    Report Date
    July 24, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 21JUN2023. H6: INVESTIGATION SUMMARY: SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITH WHAT APPEARS TO BE SILICONE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2201090,2201124,2202022,2203136,2203144,2005355,2205096,2205118,2206107 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. RETAINED SAMPLES FROM THE SAME LOTS WERE EVALUATED, NO DEFECTS OR ISSUES OBSERVED. 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 ALL LOTS 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.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 2201090, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, H.4. DEVICE MANUFACTURE DATE: 12-JAN-2022, D.4. MEDICAL DEVICE LOT #: 2201124, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-DEC-2026, H.4. DEVICE MANUFACTURE DATE: 24-JAN-2022, D.4. MEDICAL DEVICE LOT #: 2202022, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027, H.4. DEVICE MANUFACTURE DATE: 26-JAN-2022, D.4. MEDICAL DEVICE LOT #: 2203136, D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027, H.4. DEVICE MANUFACTURE DATE: 18-MAR-2022, D.4. MEDICAL DEVICE LOT #: 2203144, D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2027, H.4. DEVICE MANUFACTURE DATE: 24-MAR-2022, D.4. MEDICAL DEVICE LOT #: 2005355, D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2025, H.4. DEVICE MANUFACTURE DATE: 16-MAY-2020, D.4. MEDICAL DEVICE LOT #: 2205096, D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027, H.4. DEVICE MANUFACTURE DATE: 06-MAY-2022, D.4. MEDICAL DEVICE LOT #: 2205118, D.4. MEDICAL DEVICE EXPIRATION DATE: 30-APR-2027, H.4. DEVICE MANUFACTURE DATE: 26-MAY-2022, D.4. MEDICAL DEVICE LOT #: 2206107, D.4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2027, H.4. DEVICE MANUFACTURE DATE: 14-JUN-2022. H.3. 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

    IT WAS REPORTED THAT PRIOR TO USE WITH 9 LOTS OF BD PLASTIPAK 50ML LUER LOK SYRINGE "GREASY" FOREIGN MATTER WAS DISCOVERED IN SYRINGE. THIS OCCURRED WITH 15 EACH OF LOTS 2201090, 2201124, AND 2202022. 39 EACH OF LOTS 2203136 AND 2203144. AND 22 EACH OF LOTS 2005355, 2205096, 2205118 AND 2206107. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WE HAVE RECEIVED A REPORT FROM ONE OF OUR CUSTOMERS THAT THERE IS AN UNKNOWN GREASY SUBSTANCE ON THE PISTON, POSSIBLY A LOT OF SILICONE OIL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 9 LOTS OF BD PLASTIPAK 50ML LUER LOK SYRINGE "GREASY" FOREIGN MATTER WAS DISCOVERED IN SYRINGE. THIS OCCURRED WITH 15 EACH OF LOTS 2201090, 2201124, AND 2202022. 39 EACH OF LOTS 2203136 AND 2203144. AND 22 EACH OF LOTS 2005355, 2205096, 2205118 AND 2206107. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WE HAVE RECEIVED A REPORT FROM ONE OF OUR CUSTOMERS THAT THERE IS AN UNKNOWN GREASY SUBSTANCE ON THE PISTON, POSSIBLY A LOT OF SILICONE OIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1874561 BD PLASTIPAK 50ML LUER LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown