BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 19421588 · Received May 29, 2024

    Report

    Report Number
    3023359743-2024-00135
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Report Date
    August 22, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K212015
    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: D3 (COUNTRY TYPE AND COUNTRY), H6 (COMPONENT CODE, INVESTIGATION FINDINGS, AND 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 AS A BENT AND BROKEN CANNULA NPE. 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

    LOT # 3192210. ITEM # 320550. EMAIL DETAIL RECEIVED - CUSTOMER SAYS NEEDLE DO NOT WORK. ORIGINAL MESSAGE FROM THE CUSTOMER: "I DID NOT SAVE ALL THE BOXES THAT THE NEEDLES CAME FROM ONE OF THE LOTS IS 3192210. THE NEEDLES JUST DO NOT WORK. I HAVE BEEN THINKING I WILL GET THE DOCTOR TO CHANGE THE NEEDLES. NOT SURE WHAT YOU CAN DO BUT I CAN SEND BACK ALL THE NEEDLES THAT ARE NO GOOD IF YOU WANT. (NAME REMOVED) DC. EMAIL RECEIVED 05.07.2023. THE LAST BOX OF PEN NEEDLES NOT WORKING, SOME OF THEM CAME OUT OF WAS LOT 3192210, 330550. AWAITING SAMPLE . FIRST PIR ON CASE # (B)(4) MAIL KIT SENT 05.08.2024. THIS SECOND PIR (B)(4) MAIL KIT BEING SENT OUT 05.08.2024 DC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099870 PEN NDL 32G 4MM PRO 100 BOX 1200 US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 3192210

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown