BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9152729 · Received October 3, 2019

    Report

    Report Number
    1710034-2019-01079
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    September 18, 2019
    Report Date
    November 6, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: RECEIVED ONE UNUSED INSYTE AUTOGUARD 22GAX1.00 IN UNIT PACKAGE FROM MATERIAL NUMBER 381423, LOT NUMBER 9163647. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT. CONCLUSION(S): NO DAMAGE WAS FOUND AFTER THE INSPECTION OF ALL PARTS OF THE DEVICE. THEREFORE, BASED ON THE CUSTOMER¿S VERBATIM FEEDBACK THEY EITHER A) OBSERVED A CATHETER THAT BROKE OFF THE ADAPTER, OR B) A CATHETER-ADAPTER ASSEMBLY THAT WAS NOT PROPERLY SEATED ON THE GRIPPER ASSEMBLY. A) CATHETER WAS FIRMLY HOUSED IN THE CATHETER ADAPTOR AND NO BREAKS/DAMAGES WERE OBSERVED. B) ADAPTOR IS HELD ON THE GRIPPER ASSEMBLY BY THE CATHETER TIP ADHESION TO CANNULA. TESTING WAS PERFORMED TO SEE IF THE TIP ADHESION WAS COMPROMISED, WHICH COULD LEAD TO THE CATHETER-ADAPTOR ASSEMBLY EASILY SLIDING OFF THE HUB. THE UNIT MEASURED WITHIN THE SPECIFICATION, DEMONSTRATING THAT THE ADHESION FORCE SHOULD HAVE BEEN SUFFICIENT TO MAINTAIN INTEGRITY OF THE DEVICE THROUGH NORMAL HANDLING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE THE CATHETER WAS DISCOVERED TO BE BROKEN WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE BROKEN UPON OPENING.

    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 THAT PRIOR TO USE THE CATHETER WAS DISCOVERED TO BE BROKEN WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE CATHETER WAS FOUND TO BE BROKEN UPON OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948461 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9163647 30382903814238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other