BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    0.5ML 31GX6MM U-100 INSULIN SYRINGE

    MDR report key: 12298923 · Received August 10, 2021

    Report

    Report Number
    1920898-2021-00880
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 11, 2021
    Report Date
    July 28, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    00681131138369
    PMA / PMN Number
    K024112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND ONE NON-CONFORMANCE WAS RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. INVESTIGATION CONCLUSION: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 0013117 FOR SCALE MARKING DEFECTIVE (DIFFICULTY UNDERSTANDING SCALE). THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING DEFECTIVE (DIFFICULTY UNDERSTANDING SCALE) ON LOT # 0013117. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 0013117 FOR DIFFICULT/UNABLE TO OPERATE (INCORRECT DOSE). THIS IS THE 1ST RELATED COMPLAINT FOR DIFFICULT/UNABLE TO OPERATE (INCORRECT DOSE) ON LOT # 0013117. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0013117. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WAS ONE (1) NOTIFICATION [200871302] NOTED FOR MISSING PRINT. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 0.5ML 31GX6MM U-100 INSULIN SYRINGE EXPERIENCED A CASE OF SCALE MARKING ISSUES, AND UNDER DOSAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER/PET OWNER REPORTED ASKING HOW TO READ THE SCALE MARKINGS ON SYRINGE. HE CHECKED WITH THE PHARMACY FIRST AND WAS MISINFORMED. PET OWNER WAS TOLD FIRST LINE THAT IS LONGER AND DARKER THAN OTHER SCALE LINES, THAT IS ALSO THE MARKER WHEN PLUNGER IS PRESSED COMPLETELY TO THE TOP, IS THE ONE UNIT LINE AND NOT THE ZERO LINE. RESULTED IN GIVING HIS DOG 2 UNITS INSTEAD OF 3 AS PRESCRIBED. PET OWNER DID NOT SEE INSTRUCTIONS ON THE UNIT LINE MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202070 0.5ML 31GX6MM U-100 INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 328520 0013117 00681131138369

    Patients

    Seq Age Sex Outcome Treatment
    1