BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 18726090 · Received February 16, 2024

    Report

    Report Number
    9616656-2024-05099
    Event Type
    Malfunction
    Date Received
    February 16, 2024
    Report Date
    May 10, 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

    10 PEN NEEDLES AFFECTED FROM THE SAME BOX. H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    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.

    Description of Event or Problem · 0

    CONSUMER REPORTED FINDING THE NEEDLE TO CLOG DURING FLOW CHECK LOT # 3032930 & 2033596 CATALOG# 320122 DATE OF EVENT UNKNOWN - THE PAST MONTHS TIME FOUND 10 PEN NEEDLES FROM THE 2N BOXES. SAMPLE STATUS DISCARD - DC (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510355 PEN NDL 32G 4MM 100BX 1200 USA NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320122 2033596 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown