BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE SFTYGLD 25X1 RB MCK

    MDR report key: 11248071 · Received January 28, 2021

    Report

    Report Number
    1213809-2021-00044
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 6, 2021
    Report Date
    February 10, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    10612479248578
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE SFTYGLD 25X1 RB MCK BROKE OFF IN THE PATIENT'S ARM AND WAS REMOVED WITHOUT ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLES ARE VERY FLIMSY AND THIS ONE BROKE OFF IN A PATIENT ARM. THE PATIENT WAS NOT AWARE AND THE MA PULLED IT OUT WITHOUT ISSUE". "THE NEEDLE BROKE OFF IN A PATIENTS ARM (NO HARM) WE WERE ABLE TO GET THE NEEDLE OUT WITHOUT EPISODE."

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE SFTYGLD 25X1 RB MCK BROKE OFF IN THE PATIENT'S ARM AND WAS REMOVED WITHOUT ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLES ARE VERY FLIMSY AND THIS ONE BROKE OFF IN A PATIENT ARM. THE PATIENT WAS NOT AWARE AND THE MA PULLED IT OUT WITHOUT ISSUE" "THE NEEDLE BROKE OFF IN A PATIENTS ARM (NO HARM) WE WERE ABLE TO GET THE NEEDLE OUT WITHOUT EPISODE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145077 NEEDLE SFTYGLD 25X1 RB MCK HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 192-N251S 0141233 10612479248578

    Patients

    Seq Age Sex Outcome Treatment
    1