BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELION INSULIN SYRINGES 3/10ML 31 GAUGE

    MDR report key: 15452370 · Received September 19, 2022

    Report

    Report Number
    1920898-2022-00628
    Event Type
    Malfunction
    Date Received
    September 19, 2022
    Date of Event
    August 24, 2022
    Report Date
    November 9, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY CUSTOMER RETURNED (9) LOOSE 0.3ML INSULIN SYRINGES. THE CUSTOMER REPORTED SYRINGES WITH CROOKED LINES ON THE BARREL. THE SAMPLES WERE EXAMINED, THEN TESTED FOR SCALE MARKING POSITION USING A 0.3ML PLUG GAUGE: THE LEADING EDGE OF THE 5- AND 30- UNIT SCALE MARKINGS FELL WITHIN SPECIFICATION. NEXT, ALL 9 SAMPLES WERE TESTED FOR FLOW, AND IT WAS OBSERVED THAT ALL 9 SYRINGES WERE ABLE TO DRAW AND EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED. THE ALLEGED ISSUES COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURNED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2080897 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE INJECTION, 20 RELION INSULIN SYRINGES 3/10ML 31 GAUGE HAS CROOKED LINES ON THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RELION PET OWNER STATED, SHE'S FIND SYRINGES WITH "CROOKED LINES ON BARREL" BEFORE INJECTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE INJECTION, 20 RELION INSULIN SYRINGES 3/10ML 31 GAUGE HAS CROOKED LINES ON THE BARREL.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RELION PET OWNER STATED, SHE'S FIND SYRINGES WITH "CROOKED LINES ON BARREL" BEFORE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2646342 RELION INSULIN SYRINGES 3/10ML 31 GAUGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328512 2080897 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown