BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK 1-ML SYRINGE

    MDR report key: 16019155 · Received December 20, 2022

    Report

    Report Number
    8041187-2022-00752
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 30, 2022
    Report Date
    January 13, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY OUR QUALITY ENGINEER INSPECTED THE 3 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION OF THE PHOTOS. HOWEVER, BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. DHR FOR SYRINGE WAS PERFORMED FOR THE BATCH 2112874 (CATALOG 303060). NO QUALITY NOTIFICATION WAS RAISED ON PAST 12 MONTHS ON SIMILAR NON-CONFORMANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD LUER-LOK 1-ML SYRINGE EXPERIENCED BLACK COLOR DUST PARTICLE IN THE SYRINGE BARREL AND IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACY STORE REPORTED TO THE HOSPITAL MANAGEMENT SAYING THAT A BLACK COLOR DUST PARTICLE IN THE 1CC TUBERCULIN SYRINGE BARREL AND IN THE PACKAGING ALSO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 10 OF THE BD LUER-LOK 1-ML SYRINGE EXPERIENCED BLACK COLOR DUST PARTICLE IN THE SYRINGE BARREL AND IN THE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHARMACY STORE REPORTED TO THE HOSPITAL MANAGEMENT SAYING THAT A BLACK COLOR DUST PARTICLE IN THE 1CC TUBERCULIN SYRINGE BARREL AND IN THE PACKAGING ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2024931 BD LUER-LOK 1-ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 2112874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown