BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 9662642 · Received February 3, 2020

    Report

    Report Number
    1710034-2020-00048
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 14, 2020
    Report Date
    March 10, 2020
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903815440
    PMA / PMN Number
    K952861
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH FOR EVALUATION. BD RECEIVED ONE PHOTOGRAPH WHICH DISPLAYED A USED 18GA BD INSYTE AUTOGUARD WINGED IV CATHETER UNIT. THE UNIT WAS IN 2 PORTIONS. PORTION 1 IS THE WINGED ADAPTER THAT HAS TRACES OF THICK MEDIA AND PORTION 2 IS THE NEEDLE/HUB ASSEMBLY THAT IS FULLY RETRACTED WITHIN THE SAFETY SHIELD (BARREL). IN THE PHOTO IS A VACUTAINER HOLDER WITH TRACES OF MEDIA AND A HAND WRITTEN NOTE WITH LOT # 9241791. THE PHOTO PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. 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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER CANNULA CAME APART DURING THE NIGHT AND REMAINED IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE NIGHT A CANNULA FROM AN IV CATHETER CAME APART AND THE PLASTIC CANNULA WAS LEFT IN THE PATIENT."

    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 THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER CANNULA CAME APART DURING THE NIGHT AND REMAINED IN THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE NIGHT A CANNULA FROM AN IV CATHETER CAME APART AND THE PLASTIC CANNULA WAS LEFT IN THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126226 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 381544 9241791 30382903815440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other