BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 20918942 · Received December 12, 2024

    Report

    Report Number
    3023359743-2024-00750
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 18, 2024
    Report Date
    December 12, 2024
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201099
    PMA / PMN Number
    K213478
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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 THAT THE NEEDLES BEND DURING INJECTION. CONSUMER ALSO REPORTED THAT ONE NEEDLE BROKE OFF IN THE INJECTION SITE. CONSUMER STATED THAT SHE WENT TO THE ER TO HAVE THE NEEDLE REMOVED. NEEDLE WAS REMOVED BY THE DOCTOR. CONSUMER SAID SHE DID NOT HAVE ANY PAIN OR DISCOMFORT. CONSUMER DISCARDED THE BOX BUT WAS ABLE TO PROVIDE THE LOT # FROM THE TEAR DROP LABEL. LOT #: 9121953 CATALOG #: UNKNOWN DATE OF EVENT: 11-18-24 SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2416180 PEN NDL 31GA 8MM 100 BX 1200 USA Needle, hypodermic, single lumen FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320109 9121953 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose