BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD SHIELDED IV CATHETER

    MDR report key: 10743755 · Received October 27, 2020

    Report

    Report Number
    1710034-2020-00687
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 30, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K952861
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE SAMPLE AND PHOTOGRAPHS SUBMITTED FOR EVALUATION. BD RECEIVED ONE UNDAMAGED OPENED PACKAGE FROM REF. 381923, LOT 9193567 AND TWO PHOTOS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. DURING THE VISUAL/MICROSCOPIC EXAMINATION IT WAS OBSERVED THAT THE NEEDLE HAD PIERCED THROUGH THE TUBING WALL NEAR THE TIP CONFIRMING THE REPORTED DEFECT. NO OTHER ANOMALIES OR DAMAGES WAS OBSERVED. THIS TYPE OF DEFECT CAN OCCUR DURING THE MANUFACTURING PROCESS OR IN THE USER ENVIRONMENT. BASED ON THE LOCATION OF THE DEFECT AND SINCE THE UNIT WAS RECEIVED OUT OF ITS ORIGINAL PACKAGING, BD COULD NOT DETERMINE A DEFINITE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THIS IS A REPORT ABOUT NEEDLE THROUGH CATHETER OF INSYTE AUTOGUARD. THIS ISSUE WAS DISCOVERED DURING TRAINING OF IV INJECTION INTO A PRACTICE ARM AT A HOSPITAL AND NO HEALTH HAZARD WAS THUS REPORTED."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE PIERCED THROUGH THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THIS IS A REPORT ABOUT NEEDLE THROUGH CATHETER OF INSYTE AUTOGUARD. THIS ISSUE WAS DISCOVERED DURING TRAINING OF IV INJECTION INTO A PRACTICE ARM AT A HOSPITAL AND NO HEALTH HAZARD WAS THUS REPORTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209600 BD INSYTE AUTOGUARD SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 9193567

    Patients

    Seq Age Sex Outcome Treatment
    1