BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16882183 · Received May 5, 2023

    Report

    Report Number
    1213809-2023-00458
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    April 13, 2023
    Report Date
    May 17, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: 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 THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ TIP SYRINGE PACKAGING UNITS HAD NO PERFORATIONS BETWEEN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF THE HSO¿S HAS NOTICED AN ISSUE WITH THE PACKAGING ON THIS SYRINGE. THEY ARE TELLING ME THERE ARE NO PERFORATIONS BETWEEN EACH UNIT... THEY NOTICED THE ISSUE AND ALSO TOSSED THE SYRINGES IN QUESTION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT BD LUER-LOK¿ TIP SYRINGE PACKAGING UNITS HAD NO PERFORATIONS BETWEEN THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ONE OF THE HSO¿S HAS NOTICED AN ISSUE WITH THE PACKAGING ON THIS SYRINGE. THEY ARE TELLING ME THERE ARE NO PERFORATIONS BETWEEN EACH UNIT... THEY NOTICED THE ISSUE AND ALSO TOSSED THE SYRINGES IN QUESTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692052 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3013535 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown