BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ULTRA-FINE¿ NANO PEN NEEDLE

    MDR report key: 8287271 · Received January 29, 2019

    Report

    Report Number
    3006948883-2019-00112
    Event Type
    Injury
    Date Received
    January 29, 2019
    Date of Event
    January 9, 2019
    Report Date
    January 15, 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
    003

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: 1 PHOTO AND 1 RETURNED SAMPLE WERE INVESTIGATED AND THE ADHESIVE WAS FOUND TO BE CRACKED. HOWEVER, THE INCOMING INSPECTION REPORT OF THE CANNULA WHICH WAS USED FOR LOT# 8064006 SHOWED THAT ALL TEST RESULTS MET THE SPECIFICATIONS. 7 RETENTION SAMPLES WERE ALSO INSPECTED AND THE REPORTED DEFECT WAS NOT FOUND. A DHR OF LOT 8064006 WAS REVIEWED AND NO ABNORMALITIES/QNS WERE FOUND. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS NO FAILURE WAS FOUND AFTER REVIEWING THE LOT PRODUCTION RECORD AND MANUFACTURING PROCESS. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE PATIENT WAS INJECTED WITH "GROWTH HORMONE" FROM THE BD ULTRA-FINE¿ NANO PEN NEEDLE, THE NEEDLE BROKE OFF IN THE PATIENT'S BODY AND HAD TO BE "REMOVED BY SURGERY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77553 BD ULTRA-FINE¿ NANO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BD (SUZHOU) 8064006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention