BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ INSULIN SYRINGE

    MDR report key: 17646549 · Received August 29, 2023

    Report

    Report Number
    1920898-2023-00588
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 8, 2023
    Report Date
    September 1, 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

    H.3. 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 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# 2003391. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RED FOREIGN MATTER WAS FOUND ON THE TIP OF THE BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6), 2023, DURING THE VITREOUS INJECTION OPERATION, WHEN THE INSULIN SYRINGE WAS OPENED, A RED FLOC WAS FOUND ON THE NEEDLE TIP. REPLACING IT WITH ANOTHER SYRINGE AFTER DISCARDING. AFTER CHECKING THAT THERE WAS NO PROBLEM, PROCEED WITH THE OPERATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT RED FOREIGN MATTER WAS FOUND ON THE TIP OF THE BD ULTRA-FINE¿ INSULIN SYRINGE NEEDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON AUGUST 8TH, 2023, DURING THE VITREOUS INJECTION OPERATION, WHEN THE INSULIN SYRINGE WAS OPENED, A RED FLOC WAS FOUND ON THE NEEDLE TIP. REPLACING IT WITH ANOTHER SYRINGE AFTER DISCARDING. AFTER CHECKING THAT THERE WAS NO PROBLEM, PROCEED WITH THE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1000642 BD ULTRA-FINE¿ INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2003391

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown