BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 31G X 8MM 3B TW

    MDR report key: 11981042 · Received June 11, 2021

    Report

    Report Number
    3014704491-2021-00022
    Event Type
    Malfunction
    Date Received
    June 11, 2021
    Date of Event
    May 18, 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
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. CLOG TEST WAS CONDUCTED ON 7PCS RETENTION SAMPLES AND NO NEEDLE CLOG FAIL FOUND. BASED ON INVESTIGATION THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 PN RELION 31G X 8MM 3B TW NEEDLE WAS UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER REPORTED THAT THE NEEDLES DO NOT WORK AND ARE CLOGGED. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS PENDING 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 1 PN RELION 31G X 8MM 3B TW NEEDLE WAS UNABLE TO DELIVER INSULIN OR MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER :   THE CONSUMER REPORTED THAT THE NEEDLES DO NOT WORK AND ARE CLOGGED. DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    881938 PN RELION 31G X 8MM 3B TW HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140342

    Patients

    Seq Age Sex Outcome Treatment
    1