BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 21396726 · Received February 18, 2025

    Report

    Report Number
    3023359743-2025-00119
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Report Date
    March 13, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). 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 NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE 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 FOUND THE FIRST FEW PEN NEEDLES FROM THIS BOX TO CLOG DURING THE FLOW CHECK. TOOK PEN AND PEN NEEDLES TO PHARMACIST HE ALSO COULD NOT GET INSULIN OUT. PHARMACY PROVIDED A SAMPLE PACK OF PEN NEEDLES TO USE. DISCARDED SAMPLE OF OUR PEN NEEDLES. DC LOT # 4100049. CATALOG# 320122. DATE OF EVENT UNKNOWN SOMETIME LAST WEEK. SAMPLE STATUS DISCARD ONES WITH ISSUES. SENDING MAILING KIT FOR UNUSED SAMPLES FROM THIS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167358 PEN NDL 32G 4MM 100BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320122 4100049 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose