BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 90CT US

    MDR report key: 19075451 · Received April 9, 2024

    Report

    Report Number
    9616656-2024-05235
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Report Date
    July 3, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903205745
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS MADE TO SECTIONS D3 (COUNTRY TYPE & COUNTRY) AND 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.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 0

    CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION. DISCARDED THE BOX PROVIDED LOT NUMBER FROM A TEAR DROP LABEL LOT: 3052557 DATE OF EVENT: UNKNOWN SAMPLES: NO CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455778 PEN NDL 32G 4MM PRO 90CT US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320574 3052557 00382903205745

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown