BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9355557 · Received November 21, 2019

    Report

    Report Number
    1710034-2019-01239
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 30, 2019
    Report Date
    December 31, 2019
    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
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH PROVIDED. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED AN INSYTE AUTOGUARD PARTIALLY RETRACTED UNIT AND THE NEEDLE TIP WAS VISIBLE. THE END OF THE SAFETY BARREL DISPLAYS BREAKAGE WHICH INHIBITS THE HUB FROM FULLY RETRACTING. THE REPORTED ISSUE WAS CONFIRMED. THIS WAS SUFFICIENT EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A MISALIGNMENT OF THE GRIPPER MACHINE. DHR FOR LOT NUMBER 9101522 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT IS CHANNELED AND WHEN PRESSING THE SAFETY BUTTON OF THE CATHETER, DOES NOT RETRACT THE NEEDLE AND BREAKS IN THE BACK."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE PATIENT IS CHANNELED AND WHEN PRESSING THE SAFETY BUTTON OF THE CATHETER, DOES NOT RETRACT THE NEEDLE AND BREAKS IN THE BACK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154139 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9101522 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other