BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21445238 · Received February 24, 2025

    Report

    Report Number
    3023359743-2025-00146
    Event Type
    Malfunction
    Date Received
    February 24, 2025
    Date of Event
    February 3, 2025
    Report Date
    April 29, 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

    INVESTIGATION SUMMARY: NO PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. 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 AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO DEFINITIVE ROOT CAUSE DETERMINED AT THIS TIME. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    2 POLYBAGS IMPACTED FROM LOT#: 4100063. SEE SECTION C FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    PRODUCT NAME: BD MICROFINE PRO 32GX4MM CATALOG NUMBER: 320559, LOT NUMBER: 4100063, QUANTITY: 1 BAG, AGENCY: MEDICEO. COMPLAINT CONTENT: THERE WERE 2 BAGS OF PRODUCT WHERE THE PRINTING ON THE INSIDE BAG WAS RUBBED OFF. THEY MADE THE EXPLANATION AND HANDED OVER 1 BAG AND RETAINED 1 BAG. 4 BOXES OF THE SAME LOT WERE OPENED; THE PRINTING WAS LIKEWISE RUBBED OFF. REPLACEMENT NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528585 PEN NDL 32G 4MM PRO 14 BAG 700 CASE JPX NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320559 4100063

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown