BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOM ATRAUM WITH CLOT STOP THORACIC ANGLE SILICONE CATHETER

    MDR report key: 12853799 · Received November 22, 2021

    Report

    Report Number
    2020735-2021-00001
    Event Type
    Injury
    Date Received
    November 22, 2021
    Date of Event
    May 14, 2021
    Report Date
    November 22, 2021
    Manufacturer
    AXIOM MEDICAL INC
    Product Code
    GBS
    UDI-DI
    M665111120AT0
    PMA / PMN Number
    K883887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS WITHIN THE SCOPE OF CAPA (B)(4). DEVICE WAS DISCARDED BY HEALTHCARE FACILITY AND WAS NOT RETURNED TO THE MANUFACTURER. COMPLAINT LOG F-1B HAS BEEN REVIEWED FOR OTHER RELEVANT OR SIMILAR EVENTS. REFERENCE COMPLAINT NUMBERS AND MAKE NOTES AS NECESSARY TO DESCRIBE RELEVANCE: SALES HISTORY FOR ITEM 111120AT, LOT 1802384R, BOWERS, 1 BOX, 11-13-18 , CARDIOMEDICS, 6 BOXES, 7-13-18 AND 9-17-18, LONG BEACH MEMORIAL, 1 BOX, 10-17-18, TRI-ANIM, 9 BOXES, 6-29-18, 7-19-18, AND 2-7-19. NO COMPLAINT OTHER THAN FROM NICKLAUS CHILDREN'S HOSPITAL (TRI-ANIM) SAMPLES TESTED FROM SAME LOT PERFORMED TO SPECIFICATION AFTER BEING SOAKED PER INSTRUCTIONS ON LABEL. THE REVIEW OF IN-PROCESS CONTROLS AND REVIEW OF DEVICE FEEDBACK SUPPORT THE CONCLUSION THAT THIS IS AN ISOLATED ISSUE. THE 'CRYSTALS' REFERENCED IN THE COMPLAINT DESCRIPTION REFERS TO THE COATING BEFORE IT IS LUBRICATED, SUGGESTING THAT THE USER DID NOT SOAK THE CATHETERS PRIOR TO USE. BASED ON AVAILABLE INFORMATION, THE LIKELY ROOT CAUSE IS RELATED TO USER ERROR - NOT SOAKING THE CATHETERS PER INSTRUCTIONS. DUE TO ESG ISSUES, REPORTING WAS DELAYED TO (B)(6) 2021. ON (B)(6) 2021, A TICKET (B)(4) WAS OPENED REQUESTING WEB TRADER ACCOUNT SETUP. VERIFICATION EMAIL WAS NEVER RECEIVED AFTER INITIAL REGISTRATION. THERE HAVE BEEN TECHNICAL DIFFICULTIES GETTING A SECONDARY TEST ACCOUNT AND COMMUNICATION WITH THE ESG HELP DESK IS ONGOING AS OF DUE DATE (B)(6) 2021.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS WITHIN THE SCOPE OF CAPA (B)(4). DEVICE WAS DISCARDED BY HEALTHCARE FACILITY AND WAS NOT RETURNED TO THE MANUFACTURER. COMPLAINT LOG F-1B HAS BEEN REVIEWED FOR OTHER RELEVANT OR SIMILAR EVENTS. REFERENCE COMPLAINT NUMBERS AND MAKE NOTES AS NECESSARY TO DESCRIBE RELEVANCE: SALES HISTORY FOR ITEM 111120AT, LOT 1802384R, BOWERS, 1 BOX, 11-13-18 , CARDIOMEDICS, 6 BOXES, 7-13-18 AND 9-17-18, LONG BEACH MEMORIAL, 1 BOX, 10-17-18, TRI-ANIM, 9 BOXES, 6-29-18, 7-19-18, AND 2-7-19. NO COMPLAINT OTHER THAN FROM NICKLAUS CHILDREN'S HOSPITAL (TRI-ANIM) SAMPLES TESTED FROM SAME LOT PERFORMED TO SPECIFICATION AFTER BEING SOAKED PER INSTRUCTIONS ON LABEL. THE REVIEW OF IN-PROCESS CONTROLS AND REVIEW OF DEVICE FEEDBACK SUPPORT THE CONCLUSION THAT THIS IS AN ISOLATED ISSUE. THE 'CRYSTALS' REFERENCED IN THE COMPLAINT DESCRIPTION REFERS TO THE COATING BEFORE IT IS LUBRICATED, SUGGESTING THAT THE USER DID NOT SOAK THE CATHETERS PRIOR TO USE. BASED ON AVAILABLE INFORMATION, THE LIKELY ROOT CAUSE IS RELATED TO USER ERROR - NOT SOAKING THE CATHETERS PER INSTRUCTIONS. DUE TO ESG ISSUES, REPORTING WAS DELAYED TO (B)(6) 2021. ON (B)(6) 2021, A TICKET 275008 WAS OPENED REQUESTING WEB TRADER ACCOUNT SETUP. VERIFICATION EMAIL WAS NEVER RECEIVED AFTER INITIAL REGISTRATION. THERE HAVE BEEN TECHNICAL DIFFICULTIES GETTING A SECONDARY TEST ACCOUNT AND COMMUNICATION WITH THE ESG HELP DESK IS ONGOING AS OF DUE DATE (B)(6) 2021.

    Description of Event or Problem · 0

    CUSTOMER STATED CRYSTALLIZED MATERIAL FORMED INSIDE THE TUBE CAUSING NARROWING OF THE INNER LUMEN. CUSTOMER FLUSHED THE CATHETER WITH PLASMA-LYTE SOLUTION, PH 7.4. FOLLOWING THE FLUSH, THE PATIENT EXPERIENCED TAMPONADE. THE CUSTOMER IS CONCERNED THE CRYSTALS IN THE TUBE WERE THE CAUSE OF THE TAMPONADE.

    Description of Event or Problem · 0

    CUSTOMER STATED CRYSTALLIZED MATERIAL FORMED INSIDE THE TUBE CAUSING NARROWING OF THE INNER LUMEN. CUSTOMER FLUSHED THE CATHETER WITH PLASMA-LYTE SOLUTION, PH 7.4. FOLLOWING THE FLUSH, THE PATIENT EXPERIENCED TAMPONADE. THE CUSTOMER IS CONCERNED THE CRYSTALS IN THE TUBE WERE THE CAUSE OF THE TAMPONADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1751975 AXIOM ATRAUM WITH CLOT STOP THORACIC ANGLE SILICONE CATHETER WOUND DRAIN GBS AXIOM MEDICAL INC 111120AT 1802384R M665111120AT0

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other