BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ II INSULIN SYRINGE

    MDR report key: 13306885 · Received January 20, 2022

    Report

    Report Number
    1920898-2022-00010
    Event Type
    Malfunction
    Date Received
    January 20, 2022
    Date of Event
    December 20, 2021
    Report Date
    February 9, 2022
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 1/19/2022. H.6. INVESTIGATION: CUSTOMER RETURNED (1) 1/2CC, 8MM, 31G SYRINGE IN AN OPEN POLY BAG FROM LOT # 0153021. CUSTOMER STATES THAT THE SYRINGE IS UNABLE TO DRAW MEDICINE. THE RETURNED SYRINGE WAS TESTED AND WAS NOT ABLE TO DRAW PROPERLY. THE SAMPLE WAS THEN WIRED AND THE WIRE WAS NOT ABLE TO PASS THROUGH THE CANNULA, INDICATING AN ADHESIVE CLOG IN THE CANNULA. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 0153021. 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. ROOT CAUSE FOR THIS DEFECT CANNOT BE DETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ULTRA-FINE¿ II INSULIN SYRINGE THE DEVICE HAD DIFFICULTY OR WAS UNABLE TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY WERE "UNABLE TO DRAW THE MEDICINE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD ULTRA-FINE¿ II INSULIN SYRINGE THE DEVICE HAD DIFFICULTY OR WAS UNABLE TO ASPIRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THEY WERE "UNABLE TO DRAW THE MEDICINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519786 BD ULTRA-FINE¿ II INSULIN SYRINGE PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 0153021

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown