BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 15367278 · Received September 7, 2022

    Report

    Report Number
    1710034-2022-00481
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    August 12, 2022
    Report Date
    October 5, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    H.6. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS LEAKED FROM THE CONNECTION SITE DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE NOTED AT CONNECTION POINT OF BD ANGIOCATH 22G AND ONE-LINK CATHETER EXTENSION SET. RN NOTED LEAKING AT THE SITE OF THE CONNECTION AT THE TIME OF IV INSERTION, DURING FLUSHING. 2ND RN NOTED SAME ISSUE LAST WEEK. RN CHANGED JLOOP WITH 2 DIFFERENT LOT NUMBERS TO DETERMINE IF THERE WAS SOMETHING WRONG WITH THE JLOOP OR MAYBE CATHETER. LEAKAGE NOTED WITH BOTH CHANGES. BD 22GAX1.00IN LOT 2021886. CAT# 38523."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS LEAKED FROM THE CONNECTION SITE DURING THE FLUSH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LEAKAGE NOTED AT CONNECTION POINT OF BD ANGIOCATH 22G AND ONE-LINK CATHETER EXTENSION SET. RN NOTED LEAKING AT THE SITE OF THE CONNECTION AT THE TIME OF IV INSERTION, DURING FLUSHING. 2ND RN NOTED SAME ISSUE LAST WEEK. RN CHANGED JLOOP WITH 2 DIFFERENT LOT NUMBERS TO DETERMINE IF THERE WAS SOMETHING WRONG WITH THE JLOOP OR MAYBE CATHETER. LEAKAGE NOTED WITH BOTH CHANGES. BD 22GAX1.00IN LOT 2021886. CAT# 38523."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485442 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 2021886 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown