BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 13475097 · Received February 7, 2022

    Report

    Report Number
    2243072-2022-00162
    Event Type
    Malfunction
    Date Received
    February 7, 2022
    Date of Event
    January 25, 2022
    Report Date
    May 16, 2024
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. 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: D1: MEDICAL DEVICE BRAND NAME: BD NANO¿ 2ND GEN PEN NEEDLE. D3: MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. D4 UDI: (B)(4). THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 1006162. D4. MEDICAL DEVICE EXPIRATION DATE: 31JAN2026. H4. DEVICE MANUFACTURE DATE: 12MAR2021. D4. MEDICAL DEVICE LOT #: 0303291. D4. MEDICAL DEVICE EXPIRATION DATE: 30NOV2025. H4. DEVICE MANUFACTURE DATE: 17DEC2020. D4. MEDICAL DEVICE LOT #: 0287396. D4. MEDICAL DEVICE EXPIRATION DATE: 31OCT2025. H4. DEVICE MANUFACTURE DATE: 13OCT2020. G1: MANUFACTURING LOCATION: BECTON DICKINSON AND CO. G5: PMA/510(K)# K162516. D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 07FEB2022. H.6. INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. THIS IS THE 1ST RELATED COMPLAINT FOR THE REPORTED LOT NUMBER1006162. THIS IS THE 4TH RELATED COMPLAINT FOR THE REPORTED LOT NUMBER 0287396 AND 0303291. 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 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 NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED BD PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE PATIENT HAD TO USE A SECOND PEN NEEDLE TO COMPLETE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TAKING INJECTION, THE FLOW WILL STOP BEFORE THE COMPLETE DOSE IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN BD NANO¿ 2ND GEN PEN NEEDLE WAS UNABLE TO DELIVER INSULIN. THE PATIENT HAD TO USE A SECOND PEN NEEDLE TO COMPLETE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN TAKING INJECTION, THE FLOW WILL STOP BEFORE THE COMPLETE DOSE IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489155 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE H.10 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown