BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 14 PACK

    MDR report key: 19243324 · Received May 3, 2024

    Report

    Report Number
    3027605735-2024-00002
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 8, 2024
    Report Date
    July 25, 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

    INVESTIGATION SUMMARY: 1. DHR WAS REVIEWED AND THERE WERE NOT ANY QNS OR OTHER EVENTS THAT COULD BE RELATED TO THIS COMPLAINT. 2. PEN NEEDLE PRODUCT HAS 100% CLOG TEST IN FLOWGURU STATION, AND DEFECT PART WILL BE REJECTED BY FLOWGURU STATION AUTOMATICALLY. 3. SAMPLE RETURNED IS CONFIRMED NOT PRODUCED BY BD. 4. BASED ON THE INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED NOW. UNCONFIRMED: EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    3 PEN NEEDLES AFFECTED BY EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT HE PURCHASED TWO BOXES OF MICRO-FINE NEEDLES OF 14-PIECE (DELIVERED BY (B)(6) E-COMMERCE) AT (B)(6) STORE ON (B)(6) 2024. AFTER UNPACKING THE FIRST BOX, THREE NEEDLES WERE USED AND ALL BECAME CLOGGED , THE NEEDLE IS ASTRINGENT DURING INJECTION AND THE NEEDLE IS NOT FELT SILKY SMOOTH. THE OUTER NEEDLE CAP IS ALSO DIFFERENT FROM THE ONES PURCHASED IN THE HOSPITAL. THE MATERIAL IS VERY SOFT AND THE COLOR IS MILKY WHITE. THE CUSTOMER HAS USED BD NEEDLES BEFORE, AND THE INSULIN INJECTION IS DEGLUDEC LIRAGLUTIDE. THE NEEDLE IS REPLACED EACH TIME, THE INJECTION AREA IS THE WAIST. THE CUSTOMER SENT BACK THE FIRST BOX OF 10 NEEDLES TO THE MERCHANT, AND THE MERCHANT REFUNDED ONE BOX AND SAID THEY WOULD INVESTIGATE AND POSSIBLY PROVIDE FEEDBACK TO THE MANUFACTURER. THE CUSTOMER KEEP THE FIRST BOX OF 2 NEW NEEDLES IN HAND, WHICH CAN BE KEPT FOR ABOUT TEN DAYS AND CAN BE RETURNED. CUSTOMER'S ADDRESS IS (B)(6). CUSTOMER NEEDS A CALL OR TEXT COMPLAINT RESPONSE. THE FIRST PACKAGING BOX HAS BEEN THROWN AWAY. THE FOLLOWING INFORMATION IS PROVIDE FROM THE SECOND BOX OF NEEDLES PURCHASED AT THE SAME TIME. IT IS NOT SURE TO BE THE SAME AS THE INFORMATION ON THE FIRST BOX: PRODUCT NUMBER 329491, BATCH NUMBER 2062290, PRODUCTION DATE 2022-04-01, EXPIRY DATE 2027-03-31, REGISTRATION CERTIFICATE NUMBER: NATIONAL MEDICAL DEVICE REGISTRATION CERTIFICATE 20153140675.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141025 PEN NEEDLE 32GX4MM 14 PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329491 2062290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown