BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9135084 · Received September 30, 2019

    Report

    Report Number
    1710034-2019-01066
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    July 13, 2019
    Report Date
    October 10, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814122
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE EXTENSION SET SEPARATED FROM THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER AND LEAKED AT THE CONNECTION SITE DURING USE. LOT #'S 9128619 AND 9122769 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 6 OF 9 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED."

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 9128619. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-08. MEDICAL DEVICE LOT #: 9122769. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2019-05-02. 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 · 1

    IT WAS REPORTED THAT THE EXTENSION SET SEPARATED FROM THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER AND LEAKED AT THE CONNECTION SITE DURING USE. LOT #'S 9128619 AND 9122769 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 6 OF 9 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TWO NURSES FOR THE EXTENSION SET LEAKING AT THE SITE WHERE IT ATTACHES TO THE IV CATHETER. 2 CASES NOTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931642 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other