BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PN RELION 32G X 4MM 3B TW 50CT

    MDR report key: 18574380 · Received January 24, 2024

    Report

    Report Number
    3014704491-2024-05001
    Event Type
    Injury
    Date Received
    January 24, 2024
    Date of Event
    December 29, 2023
    Report Date
    April 18, 2024
    Manufacturer
    BECTON DICKNSONC0.,LTD. SUZHOU - CHINA
    Product Code
    FMI
    UDI-DI
    00681131386791
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION H6: DEVICE CODE. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS BENT NPE CANNULA AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER REPORTED NON PATIENT END WOULD NOT ATTACH TO INSULIN PEN PRIOR TO INJECTION. 1 PEN NEEDLE AFFECTED. LOT: 2279562, CATALOG: 320618, DATE OF EVENT: 2023-12-29, SAMPLE: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478173 PN RELION 32G X 4MM 3B TW 50CT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSONC0.,LTD. SUZHOU - CHINA 320618 2279562 00681131386791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown