BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE AUTOGUARD

    MDR report key: 20102646 · Received August 29, 2024

    Report

    Report Number
    1710034-2024-00962
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    August 9, 2024
    Report Date
    November 14, 2024
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    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

    INVESTIGATION RESULTS: THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED FROM THE CIRCUMSTANTIAL EVIDENCE THAT WAS OBSERVED ON THE RETURNED SAMPLE. ONE 20GA INSYTE AUTOGUARD UNIT FROM LOT: 4123603 WAS PROVIDED FOR INVESTIGATION. NO KINKS WERE NOTED ON THE IV CATHETER; HOWEVER, A LACK OF LUBRICATION WAS NOTED ON THE CATHETER. AS THE CATHETER HAD BEEN USED AND DECONTAMINATED, IT COULD NOT BE DETERMINED IF THE LUBRICATION WAS REMOVED FROM USE AND HANDLING OR IF IT WAS IMPROPERLY APPLIED DURING MANUFACTURING. NO OTHER SIMILAR COMPLAINTS WERE REPORTED FROM THE IMPLICATED LOT. POTENTIAL CONTRIBUTING FACTORS OF THE REPORTED ISSUE INCLUDE A LACK OF LUBRICATION, INSERTION ANGLE, AND COMPLICATIONS WITH IV PLACEMENT. THE ROOT CAUSE COULD NOT BE DETERMINED DUE TO THE SAMPLE CONDITION. THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.

    Additional Manufacturer Narrative · 0

    BATCH NUMBER 4123603 WAS REPORTED BUT NOT FOUND FOR THE REPORTED MATERIAL NUMBER 381434. 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 BDINSYTE AUTOGUARD KINKS DURING INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATES THAT THE CATHETER MATERIAL BENT WHILE THREADING CAUSING THE IV TO FAIL. PATIENT WAS SENT FOR CT CONTRAST AND THEY WERE UNABLE TO POWER INJECT THROUGH IT. THIS IS THE 3RD PIR IN THE LAST MONTH ON THIS ITEM NUMBER WITH SIMILAR ISSUES IN THIS HOSPITALS CT DEPARTMENT. 13AUG2024 NO ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1802452 BD INSYTE AUTOGUARD PERIPHERAL IV CATHETERS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown