BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿ PEN NEEDLE

    MDR report key: 8592746 · Received May 8, 2019

    Report

    Report Number
    3006948883-2019-00354
    Event Type
    Injury
    Date Received
    May 8, 2019
    Date of Event
    April 23, 2019
    Report Date
    May 28, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DHR OF LOT 8123354 WAS REVIEWED AND NO QN FOUND. INCOMING INSPECTION REPORT OF THE CANNULA WHICH USED FOR THIS LOT, AND ALL TEST RESULTS(STIFFNESS/ RESISTANCE TO BREAKAGE) MEET THE SPECIFICATION. INSPECTED 7PCS RETENTION PARTS ANGLE AND APPEARANCE, ALL RESULTS PASSED. BASED ON THE RESULTS OF 1 PCS RETURNED SAMPLES REVIEWED, WE FOUND THE CRITICAL DAMAGE MARK ON THE TOP OF ADHESIVE BEAD, IT WOULD BE CAUSED BY EXTERNAL EXCESSIVE FORCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICRO-FINE¿ PEN NEEDLE BROKE OFF IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INJECTION, IT WAS FOUND THAT NEEDLE WAS BROKEN. THEN GO TO HOSPITAL, THE BROKEN NEEDLE WAS CONFIRMED IN PATIENT'S BODY. AT PRESENT, THE BROKEN NEEDLE HAS NOT BEEN REMOVED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT BD MICRO-FINE¿ PEN NEEDLE BROKE OFF IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INJECTION, IT WAS FOUND THAT NEEDLE WAS BROKEN. THEN GO TO HOSPITAL, THE BROKEN NEEDLE WAS CONFIRMED IN PATIENT'S BODY. AT PRESENT, THE BROKEN NEEDLE HAS NOT BEEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383703 BD MICRO-FINE¿ PEN NEEDLE PEN NEEDLE FMI BD (SUZHOU) 8123354

    Patients

    Seq Age Sex Outcome Treatment
    1 Other