BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 21435359 · Received February 21, 2025

    Report

    Report Number
    1710034-2025-00296
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    February 7, 2025
    Report Date
    March 21, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826230
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382623 AND LOT NUMBER 3192240. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING LEAKS BEYOND THE BLOOD CONTROL FEATURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN STARTING SEVERAL IV'S OVER THE LAST 1-2 WEEKS THE ANGIOCATH DID NOT FUNCTION AS DESIGNED. THE INSYTE AUTOGUARD WINGED 22 GAUGE IV CATHETERS ARE DESIGNED TO HAVE NO BLEED BACK AFTER STYLET IS REMOVED. THE LAST 4 OR 5 THAT I'VE STARTED DID NOT FUNCTION AS DESIGNED. THE LAST 2 CATHERTERS WERE LOT#3192240 AND #4032939.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE. 2. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NONE. 3. COULD YOU SPECIFY THE EXACT NUMBER OF ITEMS AFFECTED FROM LOT# 3192240? 2-THAT WE ARE AWARE OF. FOR (B)(4) (MATERIAL#381523). 1. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NONE. 2. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NONE. 3. COULD YOU SPECIFY THE EXACT NUMBER OF ITEMS AFFECTED FROM LOT# 4032939? 2-THAT WE ARE AWARE OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109669 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3192240 00382903826230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown