BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ INSULIN SYRINGE

    MDR report key: 17167940 · Received June 20, 2023

    Report

    Report Number
    1920898-2023-00374
    Event Type
    Malfunction
    Date Received
    June 20, 2023
    Date of Event
    May 26, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTOS PROVIDED. CUSTOMER RETURNED THREE PHOTOS OF 30GX8MM BD SYRINGE. THE CUSTOMER REPORTED TWO BOXES OF THESE SYRINGES ARE PARTIALLY FILLED WITH A CERTAIN LIQUID, SO THE CUSTOMER FINDS THESE SYRINGES NO LONGER RELIABLE. THE PHOTOS WERE EXAMINED, AND IT¿S VERY DIFFICULT TO SEE ANY LIQUID INSIDE OF THE SYRINGES BASED ON THE PHOTO SINCE BOTH THE REPORTED LIQUID AND SYRINGES ARE BOTH CLEAR. HOWEVER, THE REPORTED ISSUE OF FOREIGN MATTER IN SYRINGE WILL BE NOTED AS CONFIRMED SO THE MANUFACTURING SITE WILL BE MADE AWARE AND CAN INVESTIGATE FURTHER. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH # 2143356. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. BASED ON THE PHOTOS RECEIVED, EMBECTA WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF FOREIGN MATTER IN SYRINGE. SINCE THERE WAS NO ROOT CAUSE FOUND, THERE IS NO CORRECTIONS FOR NOW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿+ INSULIN SYRINGE THERE WAS A MIX OF PRODUCTS IN A PACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS PURCHASED TWO BOXES OF THESE SYRINGES FROM US BUT THEY CONTAIN SYRINGES THAT ARE ALREADY PARTIALLY FILLED WITH A CERTAIN LIQUID SO THE CUSTOMER FINDS THESE SYRINGES NO LONGER RELIABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICRO-FINE¿+ INSULIN SYRINGE THERE WAS A MIX OF PRODUCTS IN A PACK. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER HAS PURCHASED TWO BOXES OF THESE SYRINGES FROM US BUT THEY CONTAIN SYRINGES THAT ARE ALREADY PARTIALLY FILLED WITH A CERTAIN LIQUID SO THE CUSTOMER FINDS THESE SYRINGES NO LONGER RELIABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692378 BD MICRO-FINE¿+ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2143356

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown