BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 13523565 · Received February 14, 2022

    Report

    Report Number
    2243072-2022-00195
    Event Type
    Malfunction
    Date Received
    February 14, 2022
    Date of Event
    January 30, 2022
    Report Date
    May 16, 2024
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D3: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. D4. MEDICAL DEVICE LOT #: 1006149 D4. MEDICAL DEVICE EXPIRATION DATE: 31DEC2025 H4. DEVICE MANUFACTURE DATE: 06JAN2021 D4. UDI: (B)(4). G1 MANUFACTURING LOCATION: BECTON DICKINSON AND CO. G5: PMA/510(K)# K212015 D9: DEVICE AVAILABLE FOR EVAL YES D9: RETURNED TO MANUFACTURER ON: 14FEB2022. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 6TH 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. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE. HENCE A POTENTIAL ROOT CAUSE CANNOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE WAS CLOGGED AND FAILED TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE ALSO CLOGS VERY EASILY AND HAD TO CHANGE NEEDLES TO COMPLETE THE INJECTION. I HAVE BEEN USING LANTUS PENS FOR YEARS AND HAVE NEVER HAD ISSUES."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ PEN NEEDLE WAS CLOGGED AND FAILED TO DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE ALSO CLOGS VERY EASILY AND HAD TO CHANGE NEEDLES TO COMPLETE THE INJECTION. I HAVE BEEN USING LANTUS PENS FOR YEARS AND HAVE NEVER HAD ISSUES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89730 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1006149 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown