BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 19656343 · Received July 2, 2024

    Report

    Report Number
    3023359743-2024-00249
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Report Date
    September 11, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K213478
    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 AND 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED BRUISING AT THE INJECTION SITE DURING INJECTION. CONSUMER ALSO REPORTED THAT THE PEN JAMS DURING INJECTION. CONSUMER RE-USES THE NEEDLE. SHE STATED THAT SHE IS USING NANO PEN NEEDLES BUT SHE DOES NOT HAVE THE BOX AND WAS NOT ABLE TO PROVIDE THE PRODUCT #. CONSUMER IS LEGALLY BLIND SO HER HUSBAND PROVIDED THE LOT # FROM THE TEAR DROP LABEL. LOT #: 4080497. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756549 PEN NDL 32G 4MM 100BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320122 4080497 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female