BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 32G X 4MM 3B TW 50CT

    MDR report key: 13388643 · Received January 28, 2022

    Report

    Report Number
    3014704491-2022-00043
    Event Type
    Malfunction
    Date Received
    January 28, 2022
    Date of Event
    January 11, 2022
    Report Date
    February 22, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. 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: D.4. MEDICAL DEVICE LOT #: 1033298 D.4. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2026 H.4. DEVICE MANUFACTURE DATE: 30-JUL-2021 D.4. MEDICAL DEVICE LOT #: UNKNOWN D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN H.4. DEVICE MANUFACTURE DATE: UNKNOWN D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 07-FEB-2022 H.6. INVESTIGATION: CUSTOMER RETURNED (2) USED 32GX4MM BD PEN NEEDLES FROM LOT# 1033298. THE CUSTOMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION. THE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT BOTH FEATURED A BENT NON-PATIENT END (NPE) CANNULA. THE BENT NPE CANNULA WOULD PREVENT PROPER FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THAT THE PEN NEEDLES WERE CLOGGED. SINCE BOTH SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. LOT#1033298 DHR WAS REVIEWED AND NO QN FOUND. THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT BY THE USER AFTER HANDLING THE PEN NEEDLES. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED PN RELION 32G X 4MM 3B TW 50CT WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED, NO INSULIN FLOW WHEN TAKING INJECTION."

    Description of Event or Problem · 0

    IT WAS REPORTED PN RELION 32G X 4MM 3B TW 50CT WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "STATED, NO INSULIN FLOW WHEN TAKING INJECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736095 PN RELION 32G X 4MM 3B TW 50CT HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown