BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.0ML BP 31G X 6MM U-40 INSULIN SYRINGE

    MDR report key: 11807153 · Received May 11, 2021

    Report

    Report Number
    1920898-2021-00539
    Event Type
    Malfunction
    Date Received
    May 11, 2021
    Date of Event
    March 25, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: 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 NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 9161795. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS. THERE WAS ONE (1) NOTIFICATION NOTED THAT DID NOT PERTAIN TO THE COMPLAINT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 1.0ML BP 31G X 6MM U-40 INSULIN SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BEEN USING BD GLIDE WITH TBL SINCE LAST 40 YEARS AND NEVER EXPERIENCED SUCH PROBLEM. SYRINGES HAVE A LEAKAGE PROBLEM AT JUNCTION OF NEEDLE AND STEM IN ALL SYRINGES I HAVE USED SO FAR .

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 1.0ML BP 31G X 6MM U-40 INSULIN SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BEEN USING BD GLIDE WITH TBL SINCE LAST 40 YEARS AND NEVER EXPERIENCED SUCH PROBLEM. SYRINGES HAVE A LEAKAGE PROBLEM AT JUNCTION OF NEEDLE AND STEM IN ALL SYRINGES I HAVE USED SO FAR .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704221 1.0ML BP 31G X 6MM U-40 INSULIN SYRINGE INSULIN SYRINGE FMF BD MEDICAL - DIABETES CARE 9161795

    Patients

    Seq Age Sex Outcome Treatment
    1