BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 16018683 · Received December 20, 2022

    Report

    Report Number
    1920898-2022-00894
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 20, 2022
    Report Date
    January 9, 2023
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1221371. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS BLOCKED AND COULDN'T DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, DUE TO DIABETES, THE PATIENT NEEDED TO BE GIVEN HUMAN INSULIN INJECTION HYPOGLYCEMIC TREATMENT BEFORE MEALS. DURING THE PROCESS OF PUMPING INSULIN, INSULIN COULD NOT BE PUMPED OUT WITH AN INSULIN SYRINGE, SO IT WAS REPLACED IMMEDIATELY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE WAS BLOCKED AND COULDN'T DELIVER INSULIN DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, DUE TO DIABETES, THE PATIENT NEEDED TO BE GIVEN HUMAN INSULIN INJECTION HYPOGLYCEMIC TREATMENT BEFORE MEALS. DURING THE PROCESS OF PUMPING INSULIN, INSULIN COULD NOT BE PUMPED OUT WITH AN INSULIN SYRINGE, SO IT WAS REPLACED IMMEDIATELY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052206 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1221371

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown