BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGE

    MDR report key: 13715866 · Received March 9, 2022

    Report

    Report Number
    1920898-2022-00154
    Event Type
    Malfunction
    Date Received
    March 9, 2022
    Date of Event
    February 24, 2022
    Report Date
    March 15, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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# 1172696. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT DID NOT PERTAIN TO THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION INSULIN SYRINGE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE SYRINGE APPEARS TO BE SLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RELION INSULIN SYRINGE EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE SYRINGE APPEARS TO BE SLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2538150 RELION INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 1172696 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown