BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 17187874 · Received June 22, 2023

    Report

    Report Number
    1920898-2023-00383
    Event Type
    Malfunction
    Date Received
    June 22, 2023
    Date of Event
    May 20, 2023
    Report Date
    July 6, 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# 1242485. ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATIONS.

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #:(B)(6). 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 EXPERIENCED DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WENT TO HOSPITAL DUE TO DIABETES WITH MULTIPLE COMPLICATIONS. ON MAY 20TH, 2023, THE PACKAGING OF SYRINGE WAS FOUND DAMAGED DURING THE INJECTION TREATMENT AND COULD NOT BE USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ULTRA-FINE¿ INSULIN SYRINGE EXPERIENCED DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WENT TO HOSPITAL DUE TO DIABETES WITH MULTIPLE COMPLICATIONS. ON (B)(6) 2023, THE PACKAGING OF SYRINGE WAS FOUND DAMAGED DURING THE INJECTION TREATMENT AND COULD NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750120 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 1242485

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown