BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 10872952 · Received November 19, 2020

    Report

    Report Number
    1920898-2020-01599
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 27, 2020
    Report Date
    January 8, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: CUSTOMER RETURNED (1) LOOSE 1/2CC, 89MM SYRINGE. CUSTOMER STATES THAT WHEN DRAWING UP INSULIN THERE WAS A DEEP COLORED TURQUOISE COLORED LIQUID THAT CAME OUT. THE RETURNED SYRINGE WAS EXAMINED AND WAS RETURNED WITH APPROXIMATELY 20 UNITS OF A BLUE LIQUID IN THE BARREL. A SMALL PORTION OF THIS MATERIAL WAS REMOVED FROM THE SAMPLE AND PREPARED FOR FTIR SPECTRAL ANALYSIS. THE SPECTRAL ANALYSIS SHOWS THAT THIS MATERIAL IS MOST LIKELY INSULIN, WHICH WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0132242. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE NOTIFICATION [200894774] NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE BLUE LIQUID WOULD NOT HAVE BEEN ACQUIRED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328468 BATCH NO. 0132242. IT WAS REPORTED THAT WHEN DRAWING UP INSULIN THERE WAS A DEEP COLORED TURQUOISE COLORED LIQUID THAT CAME OUT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER 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. FDA DEVICE PROBLEM CODE: 2944. FDA PATIENT PROBLEM CODE: 2645.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328468 BATCH NO. 0132242 IT WAS REPORTED THAT WHEN DRAWING UP INSULIN THERE WAS A DEEP COLORED TURQUOISE COLORED LIQUID THAT CAME OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337887 SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328468 0132242 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1