BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER

    MDR report key: 17819604 · Received September 26, 2023

    Report

    Report Number
    1710034-2023-01105
    Event Type
    Injury
    Date Received
    September 26, 2023
    Date of Event
    August 5, 2023
    Report Date
    October 25, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    30382903825234
    PMA / PMN Number
    K110443
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP EMDR FOR DEVICE EVALUATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 3083896, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E.4. FDA NOTIFIED?: THE INITIAL REPORTER ALSO NOTIFIED THE FDA VIA MEDWATCH # MW5144640. H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BROKE OFF IN THE PATIENT'S VEIN WHILE WITHDRAWING IT, AND PLANS WERE MADE TO SURGICALLY REMOVE THE BROKEN PIECE. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV INSERTED, VEIN BLOWN, UPON WITHDRAWAL TEAM MEMBER FELT A "POP". NOTED CATHETER WAS SHORTER, 4 MM OF IV CATHETER REMAINED IN PATIENT. I&D PLANNED TO REMOVE RETAINED FOREIGN BODY; WILL RETURN PRODUCT FRAGMENT TO MANUFACTURER." UNFORTUNATELY, THE PRODUCT IS NOT AVAILABLE TO SHIP BACK. I FOUND OUT AFTER COMPLETING THIS REPORT, THAT THE FRAGMENT WAS GIVEN TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER BROKE OFF IN THE PATIENT'S VEIN WHILE WITHDRAWING IT, AND PLANS WERE MADE TO SURGICALLY REMOVE THE BROKEN PIECE. NO FURTHER INFORMATION WAS PROVIDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IV INSERTED, VEIN BLOWN, UPON WITHDRAWAL TEAM MEMBER FELT A "POP". NOTED CATHETER WAS SHORTER, 4 MM OF IV CATHETER REMAINED IN PATIENT. I&D PLANNED TO REMOVE RETAINED FOREIGN BODY; WILL RETURN PRODUCT. FRAGMENT TO MANUFACTURER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723875 BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 3083896 30382903825234

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention