BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE AUTOGUARD BL 22GA X 1.0IN

    MDR report key: 19994808 · Received August 15, 2024

    Report

    Report Number
    1710034-2024-00879
    Event Type
    Malfunction
    Date Received
    August 15, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903814237
    PMA / PMN Number
    K201075
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381423 AND LOT NUMBER 4091426. 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

    MATERIAL# 381423, BATCH# 4091426. IT WAS REPORTED BY CUSTOMER THAT THE MATERIAL IS DIFFERENT, AND THE CATHETER DOESN'T ADVANCE AS IT USED TO. WE¿VE FOUND MORE BENDS IN THE CATHETER THEMSELVES WHEN WE REMOVE THEM. SAID THAT THE CATHETER FRAYED WHEN THEY WERE INSERTING IT INTO THE VEIN. VERBATIM: REPORTED THE MATERIAL IS DIFFERENT AND THE CATHETER DOESN'T ADVANCE AS IT USED TO. WE¿VE FOUND MORE BENDS IN THE CATHETER THEMSELVES WHEN WE REMOVE THEM. SAID THAT THE CATHETER FRAYED WHEN THEY WERE INSERTING IT INTO THE VEIN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895383 INSYTE AUTOGUARD BL 22GA X 1.0IN CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON 4091426 00382903814237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown