BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC

    MDR report key: 8671602 · Received June 5, 2019

    Report

    Report Number
    1710034-2019-00596
    Event Type
    Malfunction
    Date Received
    June 5, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903826125
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED AN UNUSED 24 GAUGE INSYTE AUTOGUARD BLOOD CONTROL UNIT FROM LOT 9002924 FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNIT AND OBSERVED A PIECE OF BROWN FOREIGN MATTER PRESENT INSIDE OF THE PACKAGE. BASED OFF THE VISUAL INSPECTION THE ENGINEER WAS ABLE TO VERIFY THE REPORTED DEFECT. THE BROWN PARTICLE WAS IDENTIFIED TO BE A SLIVER OF WOOD. THE FOREIGN MATTER WAS INTRODUCED DURING THE MANUFACTURING OR PACKAGING PROCESS. WOOD PALLETS ARE USED IN THE PACKAGING AREA THAT IS SEPARATE FROM ASSEMBLY IN THE CONTROLLED ENVIRONMENT. POTENTIAL CAUSE IS RELATED TO ASSOCIATES' MOVEMENT BETWEEN THE PACKAGING AREA AND THE CONTROLLED ENVIRONMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITH A 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SECOND IV (BD INSYTE AUTOGUARD BC WINGED 24 GA) HAS WHAT IT APPEARS TO BE A WOOD CHIP IN THE PACKAGING OF THE UNOPENED PRODUCT." 1 OF 2 COMPLAINTS.

    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 FOREIGN MATTER WAS FOUND WITH A 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE SECOND IV (BD INSYTE AUTOGUARD BC WINGED 24 GA) HAS WHAT IT APPEARS TO BE A WOOD CHIP IN THE PACKAGING OF THE UNOPENED PRODUCT." 1 OF 2 COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466033 24G X 0.75IN (0.7 X 19 MM) INSYTE AUTOGUARD BC INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9002924 30382903826125

    Patients

    Seq Age Sex Outcome Treatment
    1 Other