BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 18177744 · Received November 20, 2023

    Report

    Report Number
    1213809-2023-01306
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 25, 2023
    Report Date
    January 26, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059028
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 9151418 FOLLOW UP REPORT FOR CORRECTION. THIS COMPLAINT WAS FOUND TO BE A DUPLICATE AFTER THE MDR WAS SUBMITTED, PLEASE REFER TO MDR 9146901.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    PR 9151418 IS A DUPLICATE COMPLAINT AND WILL BE CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETY-LOK NEEDLE PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THEY NOW HAVE HAD ONE OF THE SAFETY GLIDE NEEDLES STUCK IN A PATIENT¿S LEG AND THEY ARE LOOKING FOR SOME SORT OF SOLUTION OR PLAN AND WANT TO SET UP A MEETING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2089488 BD SAFETY-LOK SAFETYGLIDE NEEDLES FMI BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903059028

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown