BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK 3ML SYRINGE

    MDR report key: 9161558 · Received October 7, 2019

    Report

    Report Number
    1213809-2019-01004
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 19, 2019
    Report Date
    December 3, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. DURING PRODUCTION OF ONE OF THE REPORTED BATCHES (8240729), AN ISSUE OF MISSING PRINT WAS IDENTIFIED AND ADDITIONAL MEASURES WERE TAKEN TO ASSURE RELEASE OF THE PRODUCT. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. NO CORRECTIVE ACTIONS RECOMMENDED SINCE SAMPLES/PHOTOS WERE NOT RECEIVED TO CONFIRM THE PRODUCT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ 3ML SYRINGES ARE DAMAGED, HAVE FOREIGN MATTER, AND/OR SCALE MARKING ISSUES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED, FM, SCALE MARKING ISSUE.

    Additional Manufacturer Narrative · 1

    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: MEDICAL DEVICE LOT #: 8140548. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-05-20. MEDICAL DEVICE LOT #: 8240729. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-28. MEDICAL DEVICE LOT #: 8098580. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-04-08. MEDICAL DEVICE LOT #: 8054540. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-02-23. MEDICAL DEVICE LOT #: 8020529. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2018-01-20. MEDICAL DEVICE LOT #: 8073753. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-14. MEDICAL DEVICE LOT #: 8154742. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-06-03. MEDICAL DEVICE LOT #: 8166581. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-06-15. MEDICAL DEVICE LOT #: 8238586. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-26. MEDICAL DEVICE LOT #: 8272888. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-09-29. MEDICAL DEVICE LOT #: 8282549. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-09. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ 3ML SYRINGES ARE DAMAGED, HAVE FOREIGN MATTER, AND/OR SCALE MARKING ISSUES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DAMAGED, FM, SCALE MARKING ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958774 BD LUER-LOK 3ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other