BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC GRN 18GA X 1.16IN

    MDR report key: 22202740 · Received June 13, 2025

    Report

    Report Number
    1710034-2025-01013
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 21, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825448
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT OF A LEAK WAS CONFIRMED FROM THE CIRCUMSTANTIAL EVIDENCE THAT WAS OBSERVED ON THE RETURNED SAMPLE. ONE FULLY RETRACTED NEEDLE WAS RECEIVED WITH BLOOD RESIDUE WITHIN THE GRIP AND BARREL. THE IV CATHETER WAS NOT RETURNED WITH THE SHIELDED NEEDLE. THE LEAK PATH COULD NOT BE DETERMINED DUE TO THE SAMPLE CONDITION; HOWEVER, AS THE SAMPLE SUPPORTS THE COMPLAINANT¿S DESCRIPTION OF THE REPORTED EVENT, THE COMPLAINT WAS CONFIRMED. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO RELATED ISSUES WITH THE MANUFACTURING PROCESS. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Description of Event or Problem · 0

    EVENT DETAILS: IT WAS REPORTED BY CUSTOMER THAT I HAVE ANOTHER CATHETER THAT HAD A SIGNIFICANT BACK FLASH THROUGH THE END OF THE CATHETER. BLOOD RETURNED OUT THE BACK END OF THE CATHETER VERBATIM: MATERIAL #382544, LOT #5010456. I HAVE ANOTHER CATHETER THAT HAD A SIGNIFICANT BACK FLASH THROUGH THE END OF THE CATHETER. DO YOU NEED ME TO SAVE THAT ONE AS WELL? DATE (B)(6) 2025: BD INSYTE AUTOGUARD BC 18 G X 1.16 IN LOT 5010456. NO PT HARM JUST A BIG BLOODY MESS. BLOOD RETURNED OUT THE BACK END OF THE CATHETER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375985 INSYTE AUTOG BC GRN 18GA X 1.16IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 5010456 00382903825448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown