BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 14BAG 700CAS JP

    MDR report key: 21138086 · Received January 13, 2025

    Report

    Report Number
    3023359743-2025-00042
    Event Type
    Malfunction
    Date Received
    January 13, 2025
    Date of Event
    December 20, 2024
    Report Date
    March 4, 2025
    Manufacturer
    EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    3 PEN NEEDLES IMPACTED FROM LOT # 4002159.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. CORRECTIONS MADE TO SECTION H6 (TYPE OF INVESTIGATION & INVESTIGATION CONCLUSIONS). 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

    WHEN DID IT OCCUR? : DURING USE. NEEDLE INJURY: NO. OTHER TREATMENT: NO WERE THE RETURNED ITEMS USED? : YES. IF USED, WAS ANYTHING ADHERED TO IT? : NO. RETURNED QUANTITY: (B)(4). DETAILS OF THE EVENT (TIMELINE, HISTORY, ETC.): PRODUCT NAME: BD MICROFINE PLUS 31GX8MM CATALOG NUMBER: 320102. LOT NUMBER: 4002159. QUANTITY: (B)(4). PRODUCT 320102. FROM A CLIENT VETERINARY HOSPITAL (XXXXX), "WE WERE CONTACTED BECAUSE THREE NEEDLES DID NOT COME OUT WHEN TESTING THE MEDICINE.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516600 PEN NDL 31GA 8MM 14BAG 700CAS JP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320102 4002159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose