BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 5B 28CT

    MDR report key: 21404670 · Received February 18, 2025

    Report

    Report Number
    3027605735-2025-00015
    Event Type
    Malfunction
    Date Received
    February 18, 2025
    Date of Event
    January 20, 2025
    Report Date
    March 11, 2025
    Manufacturer
    EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    4 PEN NEEDLES IMPACTED FROM LOT # 2243106.

    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

    THE CUSTOMER REPORTED TO THE PHARMACY THAT THE NEEDLE WAS LEAKING. CUSTOMER PURCHASED A BOX OF 28CT NEEDLES ON (B)(6) , AND USED 3 NEEDLES AT HOME, ALL THESE 3 NEEDLES LEAKED LIQUID FROM THE CONNECTION BETWEEN THE CANNULA AND THE HUB. THEN CUSTOMER WENT TO THE PHARMACY, THEY OPENED A NEW NEEDLE FOR TESTING, AND IT STILL LEAKED. CUSTOMER USED A NEW NEEDLE FOR EACH INJECTION, CUSTOMER DID NOT PROVIDE THE BRAND OF INJECTION PEN, NEEDLES OF OTHER BRAND WERE PURCHASED BUT NOT INSTALLED TO TEST. THE PHARMACY HAS REFUNDED THE CUSTOMER, BECAUSE THE BOX OF NEEDLES HAS BEEN OPENED AND CANNOT BE SOLD AGAIN, THE PHARMACY REQUESTS A REFUND FOR ONE BOX. NO PHOTOS, ONE SAMPLE COULD BE RETURNED, AND A PHONE CALL CUSTOMER RESPONSE IS NEEDED. SAMPLE AVAILABILITY: YES. SAMPLE AVAILABILITY DETAILS: PHYSICAL SAMPLE AVAILABLE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44172 PEN NEEDLE 32GX4MM 5B 28CT NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329497 2243106

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male