BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML LUER-LOK SYRINGE

    MDR report key: 9161924 · Received October 7, 2019

    Report

    Report Number
    1213809-2019-01007
    Event Type
    Malfunction
    Date Received
    October 7, 2019
    Date of Event
    September 19, 2019
    Report Date
    November 7, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF ALL PROVIDED LOT NUMBER(S) THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE PRODUCT WAS DISCOVERED TO BE DAMAGED, HAVE FOREIGN MATTER AS WELL AS SCALE MARKING ISSUES WITH A BD 1ML LUER-LOK¿ SYRINGE. 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 #: 7321522. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2017-11-17. MEDICAL DEVICE LOT #: 8161661. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-06-10. MEDICAL DEVICE LOT #: 8271675. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-09-28. MEDICAL DEVICE LOT #: 8275743. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-02. MEDICAL DEVICE LOT #: 8288598. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-15. MEDICAL DEVICE LOT #: 8292649. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-10-19." 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 · 1

    IT WAS REPORTED THAT PRIOR TO USE PRODUCT WAS DISCOVERED TO BE DAMAGED, HAVE FOREIGN MATTER AS WELL AS SCALE MARKING ISSUES WITH A BD 1ML LUER-LOK¿ SYRINGE. 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
    958760 BD 1ML LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other