BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21504805 · Received March 3, 2025

    Report

    Report Number
    3023359743-2025-00164
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    February 6, 2025
    Report Date
    March 19, 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

    CORRECTION TO: H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS BENT AND BROKEN CANNULA NPE. 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

    EVENT DESCRIPTION (NATIVE LANGUAGE) [INQUIRIES] A PATIENT REPORTED A DEFECTIVE PRODUCT. (DETAILS) SOME NEEDLES WERE BENT OR WERE NOT INSERTED. IN FEBRUARY OF LAST YEAR, THERE WAS A REPORT FROM A PATIENT REPORTED AND AN INQUIRY(0120-855-90) WAS MADE. I HAD INQUIRED VIA A SHORT EMAIL, BUT DID NOT HEAR FROM THEM AFTER THAT. I INQUIRED HERE ABOUT A DEFECTIVE PRODUCT THAT WE HAD LAST YEAR. I DO NOT KNOW THE LOT NUMBER, BUT THE PRODUCT IN QUESTION IS STORED IN A PHARMACY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    696027 PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320559 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male