BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 19299571 · Received May 13, 2024

    Report

    Report Number
    3023359743-2024-00084
    Event Type
    Malfunction
    Date Received
    May 13, 2024
    Report Date
    August 6, 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
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    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.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 0

    CONSUMER REPORTED THAT THE NEEDLE BROKE OFF IN THE INJECTION SITE DURING INJECTION. CONSUMER WAS ABLE TO REMOVE THE NEEDLE WITH A TWEEZER, NO INJURY OR DISCOMFORT, NO MEDICAL ATTENTION. CONSUMER STATED THAT SHE DOES NOT RE-USE. LOT #: 3241334 CATALOG #: 320109 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    847333 PEN NDL 31GA 8MM 100 BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320109 3241334 00382903201099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown