BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 31GX5MM 14 PACK

    MDR report key: 22047475 · Received May 19, 2025

    Report

    Report Number
    3027605735-2025-00033
    Event Type
    Malfunction
    Date Received
    May 19, 2025
    Report Date
    June 30, 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

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION). INVESTIGATION SUMMARY: RECEIVED THE FOLLOWING SAMPLE RETURNED BY THE CUSTOMER ON APRIL 22, 2025. TOTAL 2PCS, DETAILS AS BELOW SHEET. ACCORDING TO THE COMPARISON BETWEEN THE SAMPLES RETURNED BY THE CUSTOMER AND THE PRODUCTS OF EMBECTA SUZHOU, ANALYSIS BASE ON ALL THE COMPONENT (HUB, SHIELD, COVER, NEEDLE),ALL ARE INCONSISTENT WITH OUR DESIGN , ALL THE COMPONENTS ARE NOT PRODUCED OR PURCHASED BY OUR COMPANY, CONFIRM THAT THE 2PCS SAMPLES RETURNED BY THE CUSTOMER ARE NOT EMBECTA SUZHOU MADE PRODUCTS, NORMALLY CALL IT "FAKE PRODUCTS".

    Description of Event or Problem · 0

    THE PATIENT'S FAMILY MEMBER CALLED TO REPORT THAT BOUGHT 5 BOXES OF NEEDLES AT AN OFFLINE STORE OF XX AT THE BEGINNING OF THIS YEAR. THE PATIENT'S FAMILY MEMBER FOUND THAT THE NEEDLES COULD NOT PENETRATE THE SKIN, WHEN USING THE NEW NEEDLES FOR INJECTION IN MARCH AND APRIL. MATERIAL CODE IS 329490, LOT NUMBER IS 2187346, AFFECTED QUANTITY IS 2. THE PATIENT'S FAMILY MEMBER CONTACTED THE STORE TO REPLACE THE NEEDLES (REPLACED WITH MATERIAL CODE IS 329490, LOT NUMBER IS 2243094). WHEN USING A NEW REPLACEMENT NEEDLE FOR INJECTION, THE NEEDLE COULD NOT PENETRATE THE SKIN, AND THE NEEDLE FELT BENT AND THE INSULIN DOES NOT FLOW OUT. AFFECTED QUANTITY IS 1. THE PATIENT HAD DIABETES FOR MORE THAN 10 YEARS AND HAD BEEN INJECTING INSULIN FOR 7 OR 8 YEARS. THE PATIENT'S FAMILY MEMBER PERFORMED THE INJECTIONS. THE INJECTION SITE WAS IN THE ABDOMEN AND NO SUBCUTANEOUS NODULES. THE PATIENT'S FAMILY MEMBER REUSED THE NEEDLES. BUT THE AFFECTED NEEDLES WERE NEWLY OPENED AND HAD NOT BEEN REUSED. TWO INJECTIONS WERE GIVEN EVERY DAY, USING THE MIXED PROTAMINE HUMAN INSULIN INJECTION. SAMPLES SENT BY MAIL. NO PHOTOS AND CUSTOMER RESPONSE IS NEEDED BY PHONE CALL. SAMPLE AVAILABILITY: YES, SAMPLE AVAILABILITY DETAILS: PHYSICAL SAMPLE AVAILABLE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2049757 PEN NEEDLE 31GX5MM 14 PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329490 2243094

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female