BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32G 4MM 5B XTW 100CT EU

    MDR report key: 21159594 · Received January 15, 2025

    Report

    Report Number
    3023359743-2025-00051
    Event Type
    Malfunction
    Date Received
    January 15, 2025
    Report Date
    March 16, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    HI, WE GOT A CALL FROM XXXX, XXX PHARMACY, IN CC OF THIS MAIL. AN END USER INFORMED HER THAT HE/SHE IS EXPERIENCING PROBLEMS WITH THE ABOVE PEN NEEDLES. HE APPARENTLY SOMETIMES NEEDED TO USE 3 PENS BEFORE HE COULD GET THE RIGHT QUANTITY OF INSULIN IN. CONTACT XXXXX, SOMEONE ELSE MIGHT ANSWER THE PHONE BUT YOU CAN ASK FOR XXX. BATCH NR INVOLVED 4051861, EXP DATE 03/2029. CAN YOU PLEASE INVESTIGATE THIS ISSUE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1584011 PEN NEEDLE 32G 4MM 5B XTW 100CT EU NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320584 4051861

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown