BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 19480706 · Received June 6, 2024

    Report

    Report Number
    3023359743-2024-00155
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 26, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201099
    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

    3 PEN NEEDLES AFFECTED.

    Additional Manufacturer Narrative · 0

    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 TRIED 3 PEN NEEDLES TODAY WITH HER LEVIMER PEN. ALL 3 WOULD NOT ALLOW THE INSULIN TO FLOW THROUGH THEM/CLOGGED DURING INJECTION ON 1 PEN NEEDLE 2 DURING THE FLOW CHECK CLOGGED. . CALLED LEVIMER. LEVIMER INFORMED TO CALL US. SENDING MAILING KIT FOR THE 3 PEN NEEDLES. INFORMED CALLER OF PROPER NON PATIENT END PEN NEEDLES. DC LOT # 3130646. CATALOG# 320109. DATE OF EVENT 05.14.2024. SAMPLE STATUS AWAITING SAMPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1259273 PEN NDL 31GA 8MM 100 BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320109 3130646 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown