BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 13690323 · Received March 8, 2022

    Report

    Report Number
    1920898-2022-00147
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 22, 2022
    Report Date
    April 5, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    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# 1123341. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. THERE WERE ZERO (0) NOTIFICATIONS NOTED THAT PERTAINED TO THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ACCORDING TO THE USER'S REPORT, THE NEEDLE WAS FOUND TO BE BROKEN BEFORE USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE HUB SEPARATED FROM THE BD ULTRA-FINE¿ INSULIN SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ACCORDING TO THE USER'S REPORT, THE NEEDLE WAS FOUND TO BE BROKEN BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338827 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1123341

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown