BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX 1200 CA

    MDR report key: 19420291 · Received May 29, 2024

    Report

    Report Number
    3023359743-2024-00130
    Event Type
    Malfunction
    Date Received
    May 29, 2024
    Report Date
    August 23, 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

    7 PEN NEEDLE DEVICES IMPACTED BY THIS EVENT. SEE ENCLOSED ATTACHMENT FOR COMPLETED MEDWATCH SECTION C. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN B4, G6, H2, H3, H11 CORRECTION MADE TO H6 (TYPE OF INVESTIGATION AND INVESTIGATION SUMMARY) INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. 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. 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.

    Description of Event or Problem · 0

    SENT: 5/6/2024 8:44 AM. TO: (B)(4). SUBJECT: BD NANO PRO ULTRA FINE PEN NEEDLES 4MM I AM HAVING ISSUES WITH SAID NEEDLES 1 IN 10 NEEDLES DO NOT WORK, HAVE TO SWITCH TO NEW ONE WAITING THE OTHER. SO FAR I'M ABOUT THREE QUARTERS OF THE WAY THRU BOX REF 320555. LOT. 3172408. MFG 2023-07-02. EXP 2028-06-30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838560 PEN NDL 32G 4MM PRO 100 BOX 1200 CA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320555 3172408

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown