BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX

    MDR report key: 21000090 · Received December 23, 2024

    Report

    Report Number
    3023359743-2024-00778
    Event Type
    Malfunction
    Date Received
    December 23, 2024
    Date of Event
    December 2, 2024
    Report Date
    March 6, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    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 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 NOT 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

    PRODUCT NAME: BD MICROFINE PRO 32GX4MM CATALOG NUMBER: 320559. LOT NUMBER: 2012569 (A, B, C). QUANTITY: (B)(4). [INQUIRIES]: REPORT OF DEFECTIVE PRODUCT: (DETAILS). A PATIENT REPORTED THAT WHEN INJECTING, HE DID NOT FEEL ANY RESISTANCE COMPARED TO WHEN USING THE PREVIOUS PRODUCT (PLUS) AND THAT THE NEEDLE CAME OFF WHILE INJECTING. SEVERAL CORRESPONDING PRODUCTS (B)(4) WERE BROUGHT TO THE PHARMACY. REPORT FORM: NEEDED. REPLACEMENT PRODUCTS: NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628443 PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320559 2012569

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male