BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 23717679 · Received December 4, 2025

    Report

    Report Number
    9616656-2025-05003
    Event Type
    Injury
    Date Received
    December 4, 2025
    Date of Event
    November 11, 2025
    Report Date
    December 4, 2025
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K213478
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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: 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

    CONSUMER REPORTED NEEDLE BREAK, SHE STATED THAT WHEN SHE REMOVED THE NEEDLE, SHE NOTICED THAT THE NEEDLE WAS BROKEN IN HALF. CONSUMER BELIEVES THAT THE NEEDLE BROKE INSIDE OF HER, BUT SHE SAID THAT SHE IS NOT SURE. NO MEDICAL ATTENTION, NO DISCOMFORT OR PAIN. CONSUMER DOES NOT RE-USE. LOT #: 3200648. CATALOG #: 320109. DATE OF EVENT: 11-11-2025. SAMPLES: AVAILABLE - SENDING MAIL KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879414 PEN NDL 31GA 8MM 100 BX 1200 USA Needle, hypodermic, single lumen FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320109 3200648 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other