BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER

    MDR report key: 15254828 · Received August 18, 2022

    Report

    Report Number
    1710034-2022-00444
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 27, 2022
    Report Date
    October 3, 2022
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903925230
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH PROVIDED FOR EVALUATION. BD RECEIVED ONE PHOTO OF A 22GA X 1.00IN. INSYTE AUTOGUARD BC PRO UNIT. THROUGH THE VISUAL INSPECTION, THE NEEDLE IS VISIBLE PIERCING THROUGH THE CATHETER. MEDIA IS PRESENT INDICATING THAT THE DEVICE HAD BEEN USED. DURING MANUFACTURING THIS MAY OCCUR DUE TO ALIGNMENT OF THE SET TOGETHER STATION, BENT TUBING, OR AIR BLOW INCONSISTENCY. THERE IS A 100% VISION SYSTEM INSPECTION AND A SAMPLING PLAN IMPLEMENTED FOR LIE DISTANCE, WHICH MITIGATES THE OCCURRENCE OF THIS DEFECT. IN THE USER ENVIRONMENT, DURING TIP ADHESION BREAK IT IS POSSIBLE FOR THE NEEDLE TO SPEAR THROUGH THE CATHETER. BASED ON THE PROVIDED PHOTO THE CATHETER IS SLID UP THE CANNULA. IT IS ALSO POSSIBLE THAT WHILE SLIDING THE CATHETER BACK AND FORTH THE NEEDLE CAN PIERCE THROUGH THE CANNULA. SINCE THIS DEFECT IS IN THE MIDDLE OF THE CATHETER WITH THE CATHETER SLID UP THE NEEDLE AND WITH MEDIA PRESENT, THIS WAS MORE THAN LIKELY CAUSED IN THE USER ENVIRONMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS SHEARED WITH A BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "IT WAS REPORTED THAT THE CATHETER SHEARED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS SHEARED WITH A BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER "IT WAS REPORTED THAT THE CATHETER SHEARED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2818311 BD INSYTE¿ AUTOGUARD¿ BC PRO SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 392523 UNKNOWN 00382903925230

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown