BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 31G X 6MM 3B

    MDR report key: 12170399 · Received July 14, 2021

    Report

    Report Number
    3014704491-2021-00039
    Event Type
    Malfunction
    Date Received
    July 14, 2021
    Date of Event
    June 15, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FMI
    UDI-DI
    80382903206175
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 2ND 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. INVESTIGATION CONCLUSION: LOT#0140339 DHR WAS REVIEWED AND NO QN FOUND. MANUFACTURE RECORDS WERE REVIEWED, NO ABNORMALITY WAS FOUND. PEN NEEDLE PRODUCT HAS 100% CLOG TEST IN FLOWGURU STATION, AND DEFECT PART WILL BE REJECTED BY FLOWGURU STATION AUTOMATICALLY. CLOG TEST WAS CONDUCTED ON 7PCS RETENTION SAMPLES AND ALL NO NEEDLE CLOG FAIL FOUND. NO SAMPLES WERE RETURNED FOR FURTHER INVESTIGATION. BASE ON INVESTIGATION ABOVE, THE CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PN RELION 31G X 6MM 3B WAS UNABLE TO DELIVER INSULIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING 1 PEN NEEDLE TO CLOG DURING INJECTION. DOES NOT COMPLETE FLOW CHECK BEFORE INJECTIONS. CHANGED THIS PEN NEEDLE FROM BASLAGAR PEN AND COMPLETED INJECTIONS WITH ANOTHER PEN NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063074 PN RELION 31G X 6MM 3B PEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140339 80382903206175

    Patients

    Seq Age Sex Outcome Treatment
    1