BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 US

    MDR report key: 21832675 · Received April 14, 2025

    Report

    Report Number
    3023359743-2025-00283
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Report Date
    April 14, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    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: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 2ND 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 BENT NON PATIENT END CANNULA 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

    CONSUMER REPORTED PEN NEEDLE CLOG WHEN TAKING INJECTION. STATED, SHE PRIMES 1 UNIT ONLY EXPERIENCED THE PROBLEM WITH 5 PEN NEEDLES THIS MORNING BUT MORE WERE AFFECTED FROM THIS BOX BEFORE TODAY. CONSUMER DOES NOT KNOW THE DATE FOR OTHER PEN NEEDLES FAILING. LOT: 4051849. CATALOG: 320550. DATE OF EVENT: 2025-20-03. SAMPLES: YES. CONSUMER STATED, SHE WOULD PREFER THE ORIGINAL NANO PEN NEEDLES BUT THE PHARMACIST ONLY HAD THE 2ND GEN AVAILABLE. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022629 PEN NDL 32G 4MM PRO 100 BOX 1200 US Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320550 4051849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown