BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE

    MDR report key: 8670789 · Received June 5, 2019

    Report

    Report Number
    9616656-2019-00510
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 6, 2019
    Report Date
    June 28, 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
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE REMAINED STUCK IN THE INSULIN PEN VALVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: "ISSUE TWICE WITH SAFETY NEEDLES WITH DOUBLE SELF LOCKING SYSTEM FOR PEN INJECTOR. LOT 8170741, REF. 329605. THE FIRST TIME (MONDAY, (B)(6), THE NEEDLE REMAINED STUCK IN THE VALVE OF THE INSULIN PEN. UNABLE TO USE."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT THE BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE REMAINED STUCK IN THE INSULIN PEN VALVE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ISSUE TWICE WITH SAFETY NEEDLES WITH DOUBLE SELF LOCKING SYSTEM FOR PEN INJECTOR. LOT 8170741, REF. 329605. THE FIRST TIME (MONDAY, (B)(6)), THE NEEDLE REMAINED STUCK IN THE VALVE OF THE INSULIN PEN. UNABLE TO USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464716 BD AUTOSHIELD¿ DUO SAFETY PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8170741

    Patients

    Seq Age Sex Outcome Treatment
    1 Other