BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION PEN NEEDLE

    MDR report key: 11914347 · Received June 1, 2021

    Report

    Report Number
    3014704491-2021-00015
    Event Type
    Malfunction
    Date Received
    June 1, 2021
    Date of Event
    May 4, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: CUSTOMER RETURNED (22) SEALED 32GX4MM PEN NEEDLES FROM LOT# 0140357. THE CUSTOMER REPORTED THAT THE PEN NEEDLES ARE SHORTER. ALL 22 RETURNED SAMPLES WERE EXAMINED, THEN TESTED TO DETERMINE PATIENT END CANNULA LENGTH (SPECS FOR 4MM CANNULA LENGTH: 0.109¿-0.203¿). ALL OBSERVATIONS MEASURED WITHIN SPECIFICATION. NO DEFECTS WERE OBSERVED. DHR WAS REVIEWED FOR LOT#0140357 AND NO QN FOUND. BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION® PEN NEEDLE LENGTH WAS SHORTER THAN NORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL STATING THAT THE PEN NEEDLES ARE SHORTER."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RELION® PEN NEEDLE LENGTH WAS SHORTER THAN NORMAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER LEFT VOICEMAIL STATING THAT THE PEN NEEDLES ARE SHORTER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812123 RELION PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140357

    Patients

    Seq Age Sex Outcome Treatment
    1