BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 CA

    MDR report key: 19669124 · Received July 3, 2024

    Report

    Report Number
    3023359743-2024-00266
    Event Type
    Malfunction
    Date Received
    July 3, 2024
    Report Date
    September 26, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    6 DIFFERENT LOTS IMPACTED BY THIS EVENT. SEE COMPLETED MEDWATCH SECTION C FOR THE LOT COVERED UNDER THIS MDR FILING.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H11 CORRECTION MADE TO H6 (INVESTIGATION TYPE, INVESTIGATION FINDING, INVESTIGATION CONCLUSION) 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/BROKEN NPE 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 FOUND A FEW PEN NEEDLES FROM 6 DIFFERENT BOXES WITH SAME ITEM NUMBER. NEEDLES WOULD CLOG DURING THE FLOW CHECK. - AWAITING SAMPLES. UNKNOWN AMOUNTS TO EACH LOT NUMBER. ALL STORED WITHOUT FOIL TABS. UNKNOWN EVENTS DATES. LOT #: 3115881. LOT #: 2342155. LOT #: 3172410. LOT #: 3164334. LOT #: 3101694. LOT #: 3080894. CATALOG #: 320555. ALL 6 BOXES. DATE OF EVENT UNKNOWN . SAMPLE STATUS AWAITING SAMPLE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467118 PEN NDL 32G 4MM PRO 100 BOX 1200 CA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320555 3164334

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female