BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 5 ML

    MDR report key: 14776408 · Received June 22, 2022

    Report

    Report Number
    1213809-2022-00349
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 25, 2022
    Report Date
    June 27, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096466
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: ONE PARTICULATE MATTER EVALUATION FROM BRISTOL MYERS SQUIBB WAS RECEIVED. THE REPORT CONTAINED MULTIPLE PHOTOS AND SPECTRA GRAPHS. THE PHOTOS DISPLAYED A VIAL OF TRYPTIC SOY BROTH THAT CONTAINED A SMALL PARTICULATE FOREIGN MATTER. THERE WAS NO INDICATION THAT THE PRODUCT 5ML LUER LOCK SYRINGE WAS INVOLVED IN THE APPEARANCE OF FOREIGN MATTER IN THE TRYPTIC SOY BROTH IN ANY WAY. THE EVALUATION RECEIVED DOES NOT INDICATE ANY ISSUE OR PROOF OF FOREIGN MATTER ORIGINATION FROM A BD PRODUCT. THEREFORE, A POTENTIAL ROOT CAUSE COULD NOT BE ESTABLISHED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1132711. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 5 ML FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 5 ML FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2158714 BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE, 5 ML PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1132711 00382903096466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown