BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 20945342 · Received December 16, 2024

    Report

    Report Number
    3023359743-2024-00762
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    November 20, 2024
    Report Date
    February 12, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    SCHOOL NURSE REPORTED GAVE HER STUDENT INJECTION AND WENT TO RESHIELD THE PATIENT END NEEDLE WITH THE INNER SHIELD. THE NEEDLE WENT THRU THE INNER SHIELD AND POKED HER FINGER. CALLER SQUEEZED OUT THE BLOOD FROM HER SITE. WASHED WITH SOAPY WATER. FILED A STATE LNI CLAIM AND GOT A BLOOD DRAW AT LAB ON (B)(6) 2024. SHE WILL BE GOING BACK TO LAB FOR ADDITIONAL BLOOD DRAWS IN 4 WEEKS AND ALSO IN 6 MONTHS. LOT # 4023941. CATALOG# 320550. DATE OF EVENT 11.20.2024. SAMPLE STATUS DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311227 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 000000000000320550 4023941

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female