BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOG BC WING

    MDR report key: 20858741 · Received December 5, 2024

    Report

    Report Number
    1710034-2024-01442
    Event Type
    Malfunction
    Date Received
    December 5, 2024
    Date of Event
    November 13, 2024
    Report Date
    December 15, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903826339
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382633 AND LOT NUMBER 4241245. 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.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE IS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ADDITIONAL ISSUES, AS FOLLOWS: "OUR NURSING MANAGER JUST TOLD ME THAT THE OUTPATIENT DEPARTMENT HAD MORE OF THE 20GA. CATHETERS HAVE THE SLOW DELAY AND THE RETRACTION WAS PULLING THE TUBING OUT WITH THE NEEDLE, BUT IT IS NOT EVERY CATHETER. IT HAPPENED ON WEDNESDAY, (B)(6). THE LOT NUMBERS RIGHT NOW ARE #4241245 AND #4255290, SHE IS GOING TO CHECK WITH ALL THE OTHER DEPARTMENTS AND LET ME KNOW. MY QUESTION IS WHAT DO YOU WANT ME TO DO?" ADDITIONAL INFO 19 NOV 2024: WILL YOU CONFIRM THE ITEM NUMBER-IS IT BD ITEM 382633? YES, THIS IS THE ITEM. WERE THERE ANY ADVERSE EVENTS TO THE PATIENT OR CLINICIAN DUE TO THESE ISSUES? NO EVENT, JUST HAD TO STICK AGAIN. HOW MANY OCCURRENCES HAPPENED WITH LOT 4241245- SLOW RETRACTION OCCURRENCES? 1 RETRACTION PULLING THE TUBING OUT WITH THE NEEDLE 1 HOW MANY OCCURRENCES HAPPENED WITH LOT 4255290- SLOW RETRACTION OCCURRENCES? 1 RETRACTION PULLING THE TUBING OUT WITH THE NEEDLE? 0 COULD YOU PLEASE CONFIRM IF ALL THE ISSUES IDENTIFIED WITH THESE TWO LOTS OCCURRED ON 11/13? IF NOT, COULD YOU SPECIFY ANY ADDITIONAL DATES WHEN INCIDENTS OCCURRED, EVEN IF THE EXACT DATES ARE UNKNOWN? ADDITIONALLY, PLEASE PROVIDE THE NUMBER OF OCCURRENCES PER FAILURE FOR EACH EVENT DATE. RIGHT NOW, THIS IS THE ONLY EVENT DATE WITH THESE OCCURRENCES, THERE WERE A TOTAL OF THREE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289836 BD INSYTE AUTOG BC WING PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4241245 00382903826339

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown