BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9520698 · Received December 26, 2019

    Report

    Report Number
    1710034-2019-01351
    Event Type
    Malfunction
    Date Received
    December 26, 2019
    Date of Event
    December 6, 2019
    Report Date
    February 4, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903818341
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED TWO INSYTE AUTOGUARD 20GA UNITS. UNIT #1 WAS A CATHETER-ADAPTER ASSEMBLY. THE NEEDLE ASSEMBLY WAS NOT RETURNED. UNIT #2 WAS A FULL 20GA ASSEMBLY WITHIN A SEALED PACKAGE FROM LOT NUMBER 9163646. THROUGH THE VISUAL EXAMINATION OF THE FIRST UNIT, THE CATHETER REVEALED DAMAGE ON THE TUBING NEAR THE TIP. THE DAMAGE WAS CAUSED BY THE NEEDLE TIP SPEARING THROUGH THE TUBING. THE TIP LEFT A V-SHAPED CUT ALONG WITH OTHER CUTS. THERE WAS NO DAMAGE OBSERVED ON THE SECOND UNIT. THE DEFECT OF FIRST UNIT WAS CAUSED BY THE NEEDLE GOING THROUGH THE CATHETER. SINCE THE PACKAGING WAS OPENED IT CANNOT BE DETERMINED IF THE DAMAGE RESULTED FROM THE MANUFACTURING OF THE DEVICE OR FROM THE USER ENVIRONMENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE CATHETER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER HAVE BEEN BROKEN BEFORE USE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER THE CATHETER WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CATHETER HAVE BEEN BROKEN BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1317036 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381834 9163946 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other