BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN 32G X 4MM BENELUX

    MDR report key: 18836650 · Received March 5, 2024

    Report

    Report Number
    9616656-2024-05125
    Event Type
    Malfunction
    Date Received
    March 5, 2024
    Report Date
    May 28, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO E1, 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 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 NOT AVAILABLE

    Description of Event or Problem · 0

    CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. CONSUMER STATED THAT HE IS USING 8MM PEN NEEDLES BUT THE PACKAGING HAS BEEN DISCARDED SO HE DOES NOT HAVE THE PRODUCT INFORMATION. LOT #: 2033599 CATALOG #: UNKNOWN DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1883155 PN 32G X 4MM BENELUX NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320141 2033599

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown