BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER

    MDR report key: 11573167 · Received March 26, 2021

    Report

    Report Number
    1710034-2021-00241
    Event Type
    Malfunction
    Date Received
    March 26, 2021
    Date of Event
    March 3, 2021
    Report Date
    July 15, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THERE WAS NO SAMPLE OR PHOTO AVAILABLE TO BD FOR EVALUATION. THEREFORE, BD WAS UNABLE TO PERFORM A THOROUGH INVESTIGATION TO VERIFY THE REPORTED ISSUE. SINCE, AN INVESTIGATION COULD NOT BE PERFORMED BD WAS UNABLE TO DETERMINE A POSSIBLE ROOT CAUSE. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 19 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS IN LOT 0164701, AND 1 CATHETER IN LOT 0210308 LEAKED BLOOD WHEN THE CANNULA WAS RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS NO FUNCTION OF BLOOD CONTROL! WHEN CANNULA WAS RETRACTED, THE BLOOD WENT OUT OF THE HUB VERY SOON!".

    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 #: 0164701 MEDICAL DEVICE EXPIRATION DATE: 2023-05-31 DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0210308 MEDICAL DEVICE EXPIRATION DATE: 2023-07-31 DEVICE MANUFACTURE DATE: (B)(6) 2020. 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 19 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETERS IN LOT 0164701, AND 1 CATHETER IN LOT 0210308 LEAKED BLOOD WHEN THE CANNULA WAS RETRACTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE IS NO FUNCTION OF BLOOD CONTROL. WHEN CANNULA WAS RETRACTED, THE BLOOD WENT OUT OF THE HUB VERY SOON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474530 BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 0210308

    Patients

    Seq Age Sex Outcome Treatment
    1