BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFLO

    MDR report key: 23576849 · Received November 17, 2025

    Report

    Report Number
    1317056-2025-00319
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    December 30, 2016
    Report Date
    March 24, 2026
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    UDI-DI
    15051684018685
    PMA / PMN Number
    K153228
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT INFECTION CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). NO PORT DEVICE WAS RETURNED FOR EVALUATION SINCE THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION, DAMAGE OR PERFORMANCE ISSUE DURING USE. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE PACKAGING LOT REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. STERILIZATION LOAD RELEASE RECORDS WERE REVIEWED FOR THE PACKAGING LOT IN QUESTION; NO ISSUES WERE OBSERVED. THE PORT WAS IMPLANTED INTO THE PATIENT 38 DAYS PRIOR TO THE PATIENT'S INFECTION. THERE WAS NO REPORT OF PORT DEVICE MALFUNCTION OR PERFORMANCE ISSUE DURING USE. IF THE MANUFACTURING/PACKAGING/STERILIZATION OF THE PORT DEVICE IN QUESTION WAS TO CONTRIBUTE TO AN INFECTION IN THE PATIENT IT WOULD HAVE LIKELY OCCURRED SHORTLY AFTER THE IMPLANT DATE AND NOT 38 DAYS LATER. DEVICE DIRECTIONS FOR USE (DFU) CAUTIONS THAT EACH ACCESS OF THE PORT SHOULD BE PERFORMED USING ASEPTIC TECHNIQUE, FOLLOWING THE INSTITUTIONS UNIVERSAL PRECAUTIONS. THERE IS NO INDICATION FROM THE REPORTED COMPLAINT THAT THE MANUFACTURING/PACKAGING/STERILIZATION OF THE PORT DEVICE COULD HAVE CONTRIBUTED TO THE PATIENT'S INFECTION. INFECTION IS CAUTIONED IN THE DEVICE DFU AS A POTENTIAL COMPLICATION OF PORT SYSTEM USE. LABELING REVIEW: THE DIRECTION FOR USE (DFU) PROVIDED WITH THE PORT DEVICE CONTAINS THE FOLLOWING STATEMENTS: CONTRAINDICATIONS: · PRESENCE OF INFECTION, BACTEREMIA, SEPTICEMIA OR PERITONITIS. WARNINGS: · THE DEVICE IS TO BE IMPLANTED, USED, MAINTAINED AND REMOVED IN ACCORDANCE WITH CURRENT EVIDENCE-BASED GUIDANCE FOR INFECTION PREVENTION FROM AGENCIES/ORGANIZATIONS SUCH AS CENTERS OF DISEASE CONTROL (CDC) OR THE WORLD HEALTH ORGANIZATION. IT IS RECOMMENDED THAT INSTITUTIONAL POLICIES AND PROCEDURES ARE UPDATED PERIODICALLY TO REFLECT CURRENT EVIDENCE-BASED GUIDELINES FOR INFECTION PREVENTION. PRECAUTIONS: · CAREFULLY READ AND FOLLOW ALL INSTRUCTIONS PRIOR TO USE. · AFTER IMPLANTATION OR USAGE OF THE PORT, THE SYSTEM SHOULD BE FLUSHED TO CLEAR INFUSATES AND/OR BLOOD COMPONENTS IN ORDER TO MAINTAIN PATENCY. REFER TO THE "USE AND MAINTENANCE" SECTION OF THIS DFU FOR RECOMMENDATIONS. · IF MORE THAN ONE DRUG IS TO BE ADMINISTERED, BETWEEN THE INDIVIDUAL DRUG APPLICATIONS, FLUSH THE SYSTEM WITH 5 TO 10 ML NORMAL SALINE FOR INJECTION TO PREVENT DRUG INTERACTIONS. POTENTIAL COMPLICATIONS/ADVERSE EVENTS: · BACTEREMIA, · CATHETER THROMBOSIS, · CATHETER OR PORT EROSION THROUGH SKIN/VESSEL, · INFLAMMATION, · INFECTION, · IMPLANTATION SITE NECROSIS OR INFECTION, · THROMBOEMBOLISM, · THROMBOPHLEBITIS, · TUNNEL INFECTION. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT CONTINUES TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2016, PLAINTIFF UNDERWENT PLACEMENT OF THE ANGIODYNAMICS BIOFLO POWER INJECTABLE PORT, MODEL/CAT NUMBER H965440140, LOT NUMBER 5081454. THE DEVICE WAS IMPLANTED BY (B)(6), MD, AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2016, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL (B)(6) WHERE HER PORT WAS SUBSEQUENTLY REMOVED DUE TO PORT SITE INFECTION LEADING TO BACTEREMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103172 BIOFLO PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC H965440140 5081454 15051684018685

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L| O| H