BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NEEDLE 32GX4MM 7 PACK

    MDR report key: 19351873 · Received May 20, 2024

    Report

    Report Number
    3027605735-2024-00015
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Report Date
    August 12, 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 SECTIONS D3 (COUNTRY TYPE & COUNTRY) AND H6 (TYPE OF INVESTIGATION & INVESTIGATION CONCLUSIONS). 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.

    Additional Manufacturer Narrative · 0

    20 PEN NEEDLES IMPACTED FROM LOT # 2123493. SEE MEDWATCH COMPLETED SECTION C ATTACHED. H3 OTHER TEXT : DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER CALLED AND REPORTED THAT PURCHASED NEEDLES FORM ONLINE. AFTER INJECTING INSULIN ASPART30 INTO THE ABDOMEN, DEVELOPED ITCHING, REDNESS, AND SWELLING ABOUT HALF AN HOUR LATER, ALONG WITH SUBCUTANEOUS INDURATION. AFTER CHANGING THE INJECTION SITE, STILL HAD SYMPTOMS OF REDNESS, SWELLING, AND ITCHING. THE CUSTOMER HAD BEEN SWABBED WITH DERMATITIS DRUGS AND NO OBVIOUS RELIEF. THE CLIENT STATED THAT HAD USED THE SAME NEEDLE TO INJECT INSULIN ASPART30 2 MONTHS AGO WHEN THE CUSTOMER WAS HOSPITALIZED, AND THERE WERE NO ABNORMAL REACTIONS. THE CUSTOMER SUSPECTED THAT THE NEEDLES PURCHASED ONLINE ARE FAKE. INJECTIONS ARE GIVEN TWICE A DAY, AND THE NEEDLES ARE CHANGED EVERY TIME. THE CUSTOMER WAS DISINFECTED AND EXHAUSTED BEFORE INJECTION AND COULD BE STAY FOR 15SECONDS AFTER INJECTION. CURRENTLY, MORE THAN 20 NEEDLES HAVE BEEN USED AND HAVE BEEN DISCARDED. THE PRODUCT NUMBER OF THE NEEDLE IN QUESTION IS 329489, AND THE BATCH NUMBER IS 2123493. ONLINE PURCHASE TIME IS (B)(6) 2024. OTHER INFORMATION IS NOT PROVIDED COOPERATIVELY, AND THE CUSTOMER HANGS UP IN A HURRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194917 PEN NEEDLE 32GX4MM 7 PACK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA 329489 2123493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown