BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGES 3/10ML 31 GAUGE, 6MM

    MDR report key: 16133657 · Received January 10, 2023

    Report

    Report Number
    1920898-2022-00921
    Event Type
    Malfunction
    Date Received
    January 10, 2023
    Date of Event
    December 20, 2022
    Report Date
    February 15, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMI
    UDI-DI
    00681131138383
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 20-FEB-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED (10) LOOSE 0.3ML INSULIN SYRINGES. THE CUSTOMER REPORTED THAT THE SCALE MARKINGS ARE NOT PROPERLY ALIGNED. THE SAMPLES WERE EXAMINED, THEN TESTED USING A 0.3ML PLUG GAUGE. IT WAS OBSERVED THAT THE SCALE MARKINGS FOR EACH RETURNED SYRINGE FELL WITHIN THE ACCEPTED RANGE OF THE PLUG GAUGE. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE ALLEGED ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2101119 ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGES 3/10ML 31 GAUGE, 6MM THE SCALE MARKINGS HAD ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE SCALE MARKINGS ARE NOT PROPERLY ALIGNED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING RELION INSULIN SYRINGES 3/10ML 31 GAUGE, 6MM THE SCALE MARKINGS HAD ISSUES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED THAT THE SCALE MARKINGS ARE NOT PROPERLY ALIGNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205500 RELION INSULIN SYRINGES 3/10ML 31 GAUGE, 6MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL - DIABETES CARE 328521 2101119 00681131138383

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown