BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 105 BOX DE

    MDR report key: 22090688 · Received May 27, 2025

    Report

    Report Number
    3023359743-2025-00393
    Event Type
    Malfunction
    Date Received
    May 27, 2025
    Date of Event
    May 12, 2025
    Report Date
    January 27, 2026
    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

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, B5, D4 (LOT NUMBER), G6, H2, H3, H11. CORRECTION TO: H6 (TYPE OF INVESTIGATION, 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 AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. AS THE SAMPLES WERE RETURNED IN OPEN CONDITION, THE ROOT CAUSE OF THE BENT/BROKEN NON-PATIENT END CANNULA COULD NOT BE DETERMINED. 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

    COMPLAINED ABOUT 40 % CLOGGED PEN-NEEDLES IN ONE BOX (BD ULTRA-FINE PRO PEN NEEDLES, 320561).

    Description of Event or Problem · 0

    COMPLAINED ABOUT 40 % CLOGGED PEN-NEEDLES IN ONE BOX (BD ULTRA-FINE PRO PEN NEEDLES, 320561) TMAIK (B)(6) 2025. THE CUSTOMER RETURNED SAMPLES FROM LOT #3122201 AND LOT# 319224. COMPLAINT NUMBER: (B)(4) WHAT IS THE REQUEST: UPDATE LOT# FROM UNKNOWN TO 3122201 AND CREATE A NEW COMPLAINT FOR THE LOT# 319224 REASON FOR REQUEST: RECEIVED SAMPLES FROM CUSTOMER AWARENESS DATE: FOR NEW COMPLAINT AWARENESS DATE SHOULD BE TODAY I.E., 07OCT2025 ADDITIONAL INFORMATION: N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012855 PEN NDL 32G 4MM PRO 105 BOX DE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320561 3122201

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown