BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULINE SYRINGE

    MDR report key: 17699965 · Received September 7, 2023

    Report

    Report Number
    1920898-2023-00602
    Event Type
    Malfunction
    Date Received
    September 7, 2023
    Date of Event
    August 23, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138383
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 3100693. ALL INSPECTION PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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 · 0

    IT WAS REPORTED THAT THE CANNULA ON THE RELION INSULINE SYRINGE LENTGH IS INSUFFICENT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED, THE NEEDLE LENGTH IS A LOT SHORTER THAN 6MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CANNULA ON THE RELION INSULINE SYRINGE LENGTH IS INSUFFICIENT. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: CONSUMER REPORTED, THE NEEDLE LENGTH IS A LOT SHORTER THAN 6MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    925701 RELION INSULINE SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 3100693 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown