BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8278985 · Received January 25, 2019

    Report

    Report Number
    1710034-2019-00107
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Date of Event
    January 9, 2019
    Report Date
    March 11, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903814238
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: REVIEW OF THE DHR ONE NON-RELATED QN WAS INITIATED THAT WOULD IMPACT THE OUTCOME OF THE QUALITY OF THE PRODUCT RELEVANT TO THE DEFECT STATED. ALL REQUIRED CHALLENGE SAMPLES, SET-UP AND IN PROCESS TESTING WAS PERFORMED IN ACCORDANCE WITH THE QUALITY PLANS. RECEIVED ONE UNUSED IAG 22GA UNIT IN A SEALED PACKAGE WITH ¿NOT WORKING¿ WRITTEN ON THE PACKAGE FROM CATALOG NUMBER 381423, LOT NUMBER 8253952. IN ADDITION, RECEIVED ONE UNUSED IAG 22GA UNIT IN A SEALED PACKAGE WITH "WORKING CORRECTLY" WRITTEN ON THE PACKAGE. FROM CATALOG NUMBER 381423, LOT NUMBER 6179840. VISUAL/MICROSCOPIC EVALUATION: BOTH UNITS HAVE THE SAME RIB COUNT BOTH UNITS HAVE THE SAME THREAD COUNT WATER/AIR LEAK TEST: TESTING WAS PERFORMED USING A LAB SUPPLIED ISO COMPATIBLE MALE LUER TEST FITTING AND ISO COMPATIBLE LUER LOCK. TESTED THE CATHETER/ADAPTER ASSEMBLY; OBSERVED THERE WAS NO LEAKAGE IN ANY AREA OF THE CONNECTION. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT OF THE CONNECTION COMPATIBILITY OF THE RETURNED CATHETER/ADAPTER ASSEMBLIES WAS CONDUCTED TO EVALUATE THE REPORTED INCIDENT. A FLUID TEST WAS PERFORMED BY CONNECTING AN ISO STANDARD 10ML BD SYRINGE AND A RED FLUID/WATER MIX. THE FLUID FLOWED THROUGH TO THE CATHETER TIP. THERE WAS NO LEAKAGE AT THE CONNECTION SITES THE DEFECTS ADAPTER ORIENTATION INCORRECT AND LEAKAGE COULD NOT BE CONFIRMED OR REPLICATED WITH THE RETURNED UNITS. THE WERE NO CHANGES IN THE DESIGN OF THE ADAPTER. THE MATERIAL USED TO MOLD THE ADAPTER AND THE DIMENSIONS ARE SAME FOR BOTH RETURNED UNITS.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH CONNECTOR IS TOO SHORT FOR THE CONNECTION TUBING, NOT ENOUGH THREADS TO ATTACH TO.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THERE WAS AN ISSUE WITH CONNECTOR IS TOO SHORT FOR THE CONNECTION TUBING, NOT ENOUGH THREADS TO ATTACH TO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69753 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8253952 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other