BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 31GA 8MM 100 BX 1200 USA

    MDR report key: 19421595 · Received May 29, 2024

    Report

    Report Number
    3023359743-2024-00140
    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
    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 2ND 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 TIM.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 0

    CONSUMER REPORTED NEEDLE CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW. LOT #: 3130647. CATALOG #: 320109. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099877 PEN NDL 31GA 8MM 100 BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND 320109 3130647

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown