BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOG BC

    MDR report key: 20563252 · Received October 29, 2024

    Report

    Report Number
    1710034-2024-01231
    Event Type
    Malfunction
    Date Received
    October 29, 2024
    Date of Event
    October 3, 2024
    Report Date
    December 29, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903825233
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382523 AND LOT NUMBER 4190487. 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 CATHETER KINKS/BENDS DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER ADVISED THAT THE 22G INSYTE IV CATHETERS (ALL LOT NUMBER: 4190487) ARE KINKING UP INSIDE THE PATIENT'S VEINS AND ARE CAUSING THE PRESSURE ON THE INJECTOR TO GO UP A LOT. THE CATHETERS ARE TOTALLY BENT WHEN TAKEN OUT OF PATIENT. ON (B)(6) 2024: THE PATIENT WAS NOT IMPACTED. THERE WERE NO ADVERSE EVENTS OR SERIOUS INJURIES TO THE PATIENTS. THE PROBLEM WITH THE CATHETERS WAS THAT THEY WOULD EASILY BEND INSIDE THE PATIENT'S VEINS, CAUSING THE PRESSURE TO GO UP WHEN WE INJECTED CONTRAST. WE THOUGHT THE PATIENT'S VEIN BLEW AND SOMETHING WAS WRONG. WHEN WE REMOVED THE CATHETER IS WAS BENT. THIS IS AN UNUSUAL PROBLEM FOR THESE CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965537 INSYTE AUTOG BC PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4190487 00382903825233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown