BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 9110889 · Received September 24, 2019

    Report

    Report Number
    9616656-2019-00895
    Event Type
    Injury
    Date Received
    September 24, 2019
    Date of Event
    September 9, 2019
    Report Date
    September 12, 2019
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE RETURNED FOR ANALYSIS, THEREFORE THE INVESTIGATION WAS LIMITED. NO DHR REVIEW COULD BE CARRIED OUT AS LOT NUMBER IS UNKNOWN. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE'S NON-PATIENT END REMAINED IN THE "APIDRA" PEN AFTER USE, AND THE NEXT NURSE USING THE PEN RECEIVED A NEEDLE STICK INJURY FROM IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE NEEDLE NPE REMAINED IN THE PEN AND THE 1ST YEAR NURSE GOT NEEDLE STICK INJURY. A NURSE WHO USED THE PEN BEFORE THE ISSUE MAY CONNECTED THE PEN NEEDLE SLANTING. THE PEN WAS APIDRA. THE ISSUE OCCURRED IN THE EVENING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902058 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other