BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 18926509 · Received March 18, 2024

    Report

    Report Number
    9616656-2024-05158
    Event Type
    Malfunction
    Date Received
    March 18, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903201228
    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

    PRODUCT NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO D3 (COUNTRY TYPE, COUNTRY), 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 2ND. RELATED COMPLAINT 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 CLOG DURING PRIMING, STATED THAT THERE IS NO INSULIN FLOW. LOT #: 3032930. CATALOG #: 320122. SAMPLES: DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2563453 PEN NDL 32G 4MM 100BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320122 3032930 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown