BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16705140 · Received April 8, 2023

    Report

    Report Number
    1213809-2023-00335
    Event Type
    Malfunction
    Date Received
    April 8, 2023
    Date of Event
    February 16, 2023
    Report Date
    May 3, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY FOURTEEN SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE REPORTED ISSUE WAS NOT CONFIRMED UPON INSPECTION OF THE SAMPLES. NONE OF THE SAMPLES SHOWED ANY SIGNS OF THE REPORTED DEFECT. SINCE THE REPORTED DEFECT WAS NOT CONFIRMED A MANUFACTURING ROOT CAUSE COULD NOT BE DETERMINED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2030421. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 THE BD LUER-LOK¿ TIP SYRINGE HAD OIL STAINS ON/INSIDE IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING OIL STAINS, UNCLEAR SCALE LINES, AND SURFACE SCRATCHES UPON THEIR INSPECTION... NO PATIENT HARM INVOLVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE HAD OIL STAINS ON/INSIDE IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING OIL STAINS, UNCLEAR SCALE LINES, AND SURFACE SCRATCHES UPON THEIR INSPECTION... NO PATIENT HARM INVOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729893 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2030421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown