BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 6MM 3B TW 100CT US

    MDR report key: 18705346 · Received February 14, 2024

    Report

    Report Number
    9616656-2024-05087
    Event Type
    Malfunction
    Date Received
    February 14, 2024
    Report Date
    May 10, 2024
    Manufacturer
    BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
    Product Code
    FMI
    UDI-DI
    00382903207497
    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: SAMPLES WERE RECEIVED. AND AN INVESTIGATION WAS PERFORMED. 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. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM, THE INDICATED ISSUE. AND BASED ON TREND ANALYSIS, NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED, FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION. DOES NOT PRIME BEFORE INJECTION. LOT: 3073557. CATALOG: 320749. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430669 PEN NDL 32G 6MM 3B TW 100CT US NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND 320749 3073557 00382903207497

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown