BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE AUTOSHIELD DUO 30GX5MM

    MDR report key: 11263337 · Received February 1, 2021

    Report

    Report Number
    2243072-2021-00186
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    September 14, 2020
    Report Date
    March 23, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-01-25. INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LANTUS SOLOSTAR PEN. CUSTOMER STATES THAT THE NEEDLE WAS FOUND BROKEN OFF EMBEDDED AND EXPOSED IN PEN. THE RETURNED PEN WAS EXAMINED AND EXHIBITED A CANNULA STUCK IN THE SEPTUM OF THE PEN. IT IS DIFFICULT TO DETERMINE IF THE CANNULA STUCK IN THE SEPTUM OF THE PEN IS FROM A BD PRODUCT. UNABLE TO PERFORM DHR CHECK DUE TO AN UNKNOWN LOT NUMBER FOR BROKEN CANNULA NPE. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS IT IS DIFFICULT TO DETERMINE IF THE CANNULA STUCK IN THE SEPTUM OF THE PEN IS FROM A BD PRODUCT. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NEEDLE AUTOSHIELD DUO 30GX5MM BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED: NEEDLE WAS FOUND BROKEN OFF EMBEDDED AND EXPOSED IN PEN. VERBATIM: DESCRIPTION: NEAR MISS REPORTED TO 1600 AS CAUSED RISK FOR POKE INCIDENT. NEEDLE WAS FOUND BROKEN OFF IMBEDDED AND EXPOSED IN PEN. PEN UNSTABLE AND POKE RISK FROM EXPOSED SHARP. ACTION TAKEN: REPORT TO QAC."

    Additional Manufacturer Narrative · 1

    "UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4)."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NEEDLE AUTOSHIELD DUO 30GX5MM BROKE AT THE CANNULA DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED: NEEDLE WAS FOUND BROKEN OFF EMBEDDED AND EXPOSED IN PEN. VERBATIM: DESCRIPTION: NEAR MISS REPORTED TO 1600 AS CAUSED RISK FOR POKE INCIDENT. NEEDLE WAS FOUND BROKEN OFF IMBEDDED AND EXPOSED IN PEN. PEN UNSTABLE AND POKE RISK FROM EXPOSED SHARP. ACTION TAKEN: REPORT TO QAC".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159549 PEN NEEDLE AUTOSHIELD DUO 30GX5MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1