BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOFLO

    MDR report key: 20107855 · Received August 30, 2024

    Report

    Report Number
    1317056-2024-00133
    Event Type
    Injury
    Date Received
    August 30, 2024
    Date of Event
    July 29, 2022
    Report Date
    October 11, 2024
    Manufacturer
    ANGIODYNAMICS, INC
    Product Code
    LJT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF THE PORT CATHETER FRACTURE AND EXTRAVASATION (LEAK) CANNOT BE CONFIRMED SINCE NO PORT OR CATHETER DEVICE WAS RETURNED FOR EVALUATION. WITHOUT RECEIVING PRODUCT FOR EVALUATION, A ROOT CAUSE FOR THIS EVENT CANNOT BE DETERMINED. POTENTIAL ROOT CAUSE FOR A 12-MONTH INDWELLING PORT CATHETER FAILURE MODE OF CATHETER FRACTURED IS PINCH-OFF SYNDROME, WHICH IS CAUTIONED AGAINST IN THE DEVICE DFU. A DEVICE HISTORY RECORD (DHR) REVIEW OF THE PACKAGING/ASSEMBLY LOTS COULD NOT BE PERFORMED SINCE THERE WAS NO REPORTED LOT NUMBER OR DEVICE UPN PROVIDED. LABELING REVIEW: THE DFU FOR BIOFLO PORTS CONTAINS THE FOLLOWING PRECAUTIONS: PRECAUTIONS: · CAREFULLY READ AND FOLLOW ALL INSTRUCTIONS PRIOR TO USE. · ONLY LICENSED HEALTH CARE PRACTITIONERS SHOULD INSERT, MANIPULATE, AND REMOVE THESE DEVICES. INTENDED USE/ INDICATIONS FOR USE: THE BIOFLO PORT WITH ENDEXO TECHNOLOGY, BIOFLO DUAL PORT WITH ENDEXO TECHNOLOGY AND THE BIOFLO PORT WITH ENDEXO AND PASV VALVE TECHNOLOGY ARE INDICATED FOR PATIENTS WHO REQUIRE LONG-TERM ACCESS TO THE CENTRAL VENOUS SYSTEM FOR ADMINISTRATION OF FLUIDS INCLUDING BUT NOT LIMITED TO HYDRATION FLUIDS, CHEMOTHERAPY, ANALGESICS, NUTRITIONAL THERAPY AND BLOOD PRODUCTS. THE DEVICE IS ALSO INDICATED FOR BLOOD SPECIMEN WITHDRAWAL. ADVERSE EVENTS: DRUG EXTRAVASATION HEMATOMA IMPLANTATION SITE NECROSIS OR INFECTION CATHETER OCCLUSION, MALPOSITION, DISLODGMENT, FRAGMENTATION, MIGRATION, DISCONNECTION OR RUPTURE CATHETER OCCLUSION OR BREAKAGE CAUSED BY PINCHING BETWEEN CLAVICLE AND FIRST RIB CATHETER TO PORT CONNECTION: NOTE: TO ENSURE PROPER ASSEMBLY OF PORT AND SNAPLOCK CONNECTOR, A MINIMAL GAP (LESS THAN 0.5 MM) IS EXPECTED. PRECAUTION: PRIOR TO ADVANCING THE SNAP LOCK CONNECTOR, ENSURE THAT THE CATHETER IS PROPERLY POSITIONED. A CATHETER NOT ADVANCED TO THE PROPER REGION MAY NOT SEAT SECURELY AND LEAD TO DISLODGEMENT AND EXTRAVASATION. THE CATHETER MUST BE STRAIGHT WITH NO SIGN OF KINKING. A SLIGHT PULL ON THE CATHETER IS SUFFICIENT TO STRAIGHTEN IT. ADVANCING THE SNAP LOCK OVER A KINKED CATHETER MAY DAMAGE THE CATHETER. MAINTENANCE: TO HELP PREVENT CLOT FORMATION AND CATHETER BLOCKAGE, THE BIOFLO PORT SHOULD BE FILLED WITH STERILE HEPARINIZED SALINE AFTER EACH USE. BIOFLO PORTS WITH THE PASV VALVE MAY BE FLUSHED AND LOCKED WITH EITHER NORMAL SALINE OR HEPARINIZED SALINE PER INSTITUTIONAL PROTOCOL. IF THE PORT REMAINS UNUSED FOR LONG PERIODS OF TIME, THE LOCK SHOULD BE CHANGED AT LEAST ONCE EVERY FOUR WEEKS. PRECAUTION: · CAREFULLY FOLLOW THE CATHETER TO PORT CONNECTION TECHNIQUE PROVIDED IN THE DFU TO ENSURE PROPER DEVICE CONNECTION AND TO AVOID CATHETER DAMAGE. · ASSURE TIGHT CONNECTION BETWEEN PORT BODY AND CATHETER. · AFTER IMPLANTATION OR ANY TREATMENT VIA THE PORT, THE SYSTEM SHOULD BE FLUSHED WITH NORMAL SALINE FOR INJECTION PER INSTITUTIONAL PROTOCOL. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON OR ABOUT (B)(6) 2021, PLAINTIFF UNDERWENT PLACEMENT OF AN ANGIODYNAMICS BIOFLO PRODUCT. THE DEVICE WAS IMPLANTED BY DR. (B)(6), M.D., AT (B)(6) HOSPITAL IN (B)(6), FOR THE PURPOSE OF FREQUENT IV ACCESS. ON OR ABOUT (B)(6) 2022, PLAINTIFF PRESENTED HERSELF TO (B)(6) HOSPITAL DUE TO PERSISTENT PAIN AND TENDERNESS ASSOCIATED WITH THE BIOFLO. PLAINTIFF UNDERWENT A PORT CHECK WHICH DEMONSTRATED A FRACTURE IN THE CATHETER LINE OF THE DEFECTIVE DEVICE WITH FREE EXTRAVASATION INTO THE SOFT TISSUES. AS A RESULT OF HAVING THE BIOFLO IMPLANTED, PLAINTIFF HAS, ALLEGEDLY, EXPERIENCED SIGNIFICANT MENTAL AND PHYSICAL PAIN AND SUFFERING, HAS SUSTAINED PERMANENT INJURY, PERMANENT AND SUBSTANTIAL PHYSICAL DEFORMITY, HAS UNDERGONE CORRECTIVE SURGERIES, AND HAS SUFFERED FINANCIAL OR ECONOMIC LOSS, INCLUDING, BUT NOT LIMITED TO, OBLIGATIONS FOR MEDICAL SERVICES AND EXPENSES, AND PRESENT AND FUTURE LOST WAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1911377 BIOFLO PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS, INC

    Patients

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