BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9134592 · Received September 30, 2019

    Report

    Report Number
    1710034-2019-01062
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    July 1, 2019
    Report Date
    October 9, 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 SUMMARY: OBSERVATIONS AND TESTING COULD NOT BE PERFORMED BECAUSE UNITS WERE NOT RECEIVED FOR INVESTIGATION OF THIS INCIDENT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. CONCLUSION(S): INDETERMINATE: WITHOUT THE ACTUAL SAMPLE FOR EVALUATION AND TESTING THERE WAS NO PHYSICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS RELATED ISSUES FOR THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER AND EXTENSION TUBING CONNECTION SITE DURING USE. LOT'S 9128619 AND 9122769 WERE REPORTED TO HAVE BEEN INVOLVED, EACH WITH 1 OCCURRENCE OF THE EVENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: 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 LEAKAGE OCCURRED FROM THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER AND EXTENSION TUBING CONNECTION SITE DURING USE. LOT'S 9128619 AND 9122769 WERE REPORTED TO HAVE BEEN INVOLVED, EACH WITH 1 OCCURRENCE OF THE EVENT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH 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
    931718 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE SECTION H.10. 30382903814122

    Patients

    Seq Age Sex Outcome Treatment
    1 Other