BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 7 PACK

    MDR report key: 19661609 · Received July 2, 2024

    Report

    Report Number
    3027605735-2024-00044
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    June 12, 2024
    Report Date
    September 24, 2024
    Manufacturer
    EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION. FINDINGS, & INVESTIGATION CONCLUSIONS). 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 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

    CUSTOMER FEEDBACK: IN MAY, THE NEEDLES WERE PURCHASED ONLINE, ITEM NUMBER 329489, 7 NEEDLES/BOX, 4 BOXES IN TOTAL. ON JUNE 6, WHEN USING, A LIVE BLACK INSECT WAS FOUND IN THE PLASTIC PACKAGING OF ONE BOX. WORRIED THAT THE NEEDLES WERE CONTAMINATED, THE CUSTOMER HOPE TO BE COMPENSATED ACCORDING TO REGULATIONS. CAN BE PROVIDE A VIDEO OF THE PROBLEM NEEDLES, CAN COOPERATE WITH MAILING, AND NEED TO REPLY TO THE INVESTIGATION RESULTS BY PHONE. SAMPLE AVAILABILITY? YES. SAMPLE AVAILABILITY DETAILS: PICTURE/VIDEO AVAILABLE AND PHYSICAL SAMPLE. SALES ON JUNE 4 CONFIRMED WITH CUSTOMER: SALES TERMINAL IS TMALL PLATFORM, SKU#329489, BATCH#2123499, THE PURCHASE TIME IS MAY 16, 2024, TOTAL 4 BOXES OF 4MM 7-PIECE WERE BOUGHT, THE CUSTOMER CONSULTED THE SALES TERMINAL, AND ARRANGED FOR REFUNDS OF A BOX OF PRODUCTS, THE REGISTRATION CERTIFICATE# IS GXZZ-20153140675, THE OUTSIDE OF THE BOX ARE RETAINED AND CAN PROVIDE SAMPLES. ON JUNE 17, THE SAMPLES WERE SENT, EXPRESS NO.: SF1456175276759.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684335 PEN NEEDLE 32GX4MM 7 PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329489 2123499

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male