BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PN RELION 31G X 6MM

    MDR report key: 12242878 · Received July 28, 2021

    Report

    Report Number
    3014704491-2021-00051
    Event Type
    Malfunction
    Date Received
    July 28, 2021
    Date of Event
    June 29, 2021
    Report Date
    July 29, 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
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION: CUSTOMER RETURNED (4) SEALED 6MM, 31G PEN NEEDLES FROM LOT # 0140337. CUSTOMER STATES THAT THE INSULIN DOES NOT FLOW WHEN PRIMING. ALL RETURNED PEN NEEDLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. LOT#0140337 DHR WAS REVIEWED AND NO QN FOUND. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PN RELION 31G X 6MM WAS UNABLE TO DELIVER INSULIN, AND UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RELION PHARMACIST AND CONSUMER CALLED IN. CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING. STATED, HE PRIMES 2 TO 3 UNITS. STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, HE'S USING 2 OR 3 PEN NEEDLES TO COMPLETE ONE INJECTION.

    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 PN RELION 31G X 6MM WAS UNABLE TO DELIVER INSULIN, AND UNABLE TO PRIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RELION PHARMACIST AND CONSUMER CALLED IN. CONSUMER REPORTED, NO INSULIN FLOW WHEN PRIMING. STATED, HE PRIMES 2 TO 3 UNITS STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, HE'S USING 2 OR 3 PEN NEEDLES TO COMPLETE ONE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1135908 PN RELION 31G X 6MM PEN NEEDLE FMI BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140337 80382903206175

    Patients

    Seq Age Sex Outcome Treatment
    1