BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLE

    MDR report key: 14034476 · Received April 6, 2022

    Report

    Report Number
    9616656-2022-00392
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Date of Event
    March 18, 2022
    Report Date
    March 21, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY : EXEC SUMMARY - NO PHYSICAL DEVICE SAMPLES WERE RETURNED. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE COMPLAINT LOT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH. RELATED COMPLAINT FOR (NEEDLE CLOG ) ON THIS LOT # 1021328. NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. CAPA/SA - BASED ON THE ABOVE NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE OR PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) ARE REQUIRED AT THIS TIME. DHR REVIEW - A LOT HISTORY REVIEW FOR BATCH # 1021328 WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE CONSUMER REPORTED NO INSULIN FLOW. DATE OF EVENT : UNKNOWN. SAMPLES : NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840260 BD ULTRA-FINE¿ NANO¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 1021328 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown