BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER

    MDR report key: 8584235 · Received May 6, 2019

    Report

    Report Number
    1710034-2019-00501
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 15, 2019
    Report Date
    June 21, 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
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED TWO PHOTOGRAPHS AND AN EMPTY PACKAGE FROM CATALOG NUMBER 381834, LOT NUMBER 8240844. THE ACTUAL SAMPLE WAS NOT RETURNED. PHOTOGRAPH ONE DISPLAYED DAMAGE ON THE GRIP, INWARD CAUSING THE PARTIAL RETRACTION. THE DAMAGE WAS IN THE AREA AT THE BOTTOM OF THE GRIP WHERE IT CONNECTS TO THE BARREL. THE SECOND PHOTOGRAPH DISPLAYED THE LABEL INFORMATION. BASED ON THE REVIEW OF THE SUBMITTED PHOTO THE DEFECT NEEDLE REACTION FAILURE WAS CONFIRMED. THIS WAS PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM AND SUPPORT A MANUFACTURING PROCESS RELATED ISSUE FOR THE REPORTED DEFECT RELATING TO A MISALIGNMENT WHERE THE PROBE INADVERTENTLY CONTACTS THE EDGE OF THE GRIP WHICH IN TURN CAN CAUSE THE DAMAGE OBSERVED. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A NEEDLE RETRACTION FAILURE OCCURRED WITH A BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "RETRACTION FAILURE FOR CANNULA."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NEEDLE RETRACTION FAILURE OCCURRED WITH A BD INSYTE AUTOGUARD SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "RETRACTION FAILURE FOR CANNULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377998 BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTERVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 8240844 00382903818341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other