BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG 4F SINGLE-LUMEN PICC (60CM)

    MDR report key: 16628083 · Received March 28, 2023

    Report

    Report Number
    3006260740-2023-01004
    Event Type
    Injury
    Date Received
    March 28, 2023
    Date of Event
    March 2, 2023
    Report Date
    June 26, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741035326
    PMA / PMN Number
    K871998
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF A CATHETER FRACTURE IS CONFIRMED. ONE 4 FR GROSHONG CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER WAS RETURNED IN TWO SEGMENTS WITH THE PROXIMAL SEGMENT BEING ASSEMBLED WITH THE CONNECTOR ASSEMBLY. THE PROXIMAL SEGMENT EXTENDED FROM THE 20 CM CATHETER SEGMENT AND THE DISTAL SEGMENT EXTENDS FROM THE 19 CM DEPTH MARKER. DRIED RED AND WHITE USAGE RESIDUES WERE VISIBLE WITHIN THE CATHETER. THE EVENT DESCRIPTION INDICATES THE DEVICE WAS IN USE FOR APPROXIMATELY 8 MONTHS. TWO IMAGES OF THE CATHETER AND TWO RADIOGRAPHIC IMAGES WERE ALSO PROVIDED. THE IMAGES SHOWED A 4 FR GROSHONG CATHETER WITH A BREAK AT THE SAME LOCATION AS THE RETURNED SAMPLE. THE RADIOGRAPHIC IMAGES APPEARED TO SHOW A LINE SEGMENT AT THE LOCATION OF THE RIGHT LUNG. MICROSCOPIC INSPECTION OF THE BREAK LOCATION ON BOTH SEGMENTS REVEALED MATERIAL WHITENING ALONG THE BREAK EDGES. THE FRACTURES SURFACES APPEARED TO BE ROUGH AND GRANULAR. THE CATHETER WALL THICKNESS WAS MEASURED AND WAS FOUND TO BE WITHIN MANUFACTURING SPECIFICATION. THE EVENT DESCRIPTION INDICATES THE DEVICE WAS IN PATIENT USE FOR APPROXIMATELY 7 MONTHS WHICH SUGGEST A MANUFACTURING RELATED ROOT CAUSE IS UNLIKELY. BASED ON THE CHARACTERISTICS OF THE DAMAGE OBSERVED AND INFORMATION PROVIDED, LIKELY CONTRIBUTING FACTORS INCLUDE MATERIAL FATIGUE CAUSED BY REPEATED KINKING OF THE CATHETER. SINCE THE CATHETER WAS FOUND TO CONTAIN A COMPLAINT BREAK, THE COMPLAINT IS CONFIRMED. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H11.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WAS DIAGNOSED WITH ACUTE PROMYELOCYTIC LEUKEMIA AND HAD A GROSHONGPICC CATHETER INSERTED BLINDLY FROM THE LEFT MEDIAN CUBITAL VEIN BY A QUALIFIED PICC PLACEMENT NURSE AT THE HEMATOLOGY DEPARTMENT ON (B)(6) 2022. 48 CM OF THE CATHETER WAS INSERTED INTERNALLY AND ANOTHER 7 CM WAS EXPOSED EXTERNALLY. THE CATHETER TIP WAS POSITIONED IN THE SUPERIOR VENA CAVA. THE PATIENT UNDERWENT CHEMOTHERAPY AND CATHETER MAINTENANCE PERIODICALLY ON THE DOCTOR¿S ORDER, WHEN NO DISCOMFORT SYMPTOMS WERE COMPLAINED OF, SUCH AS CHEST PAIN, CHEST DISTRESS, PALPITATION AND ANHELATION. ON (B)(6) 2023, THE PATIENT WENT BACK HOSPITAL FOR CHEMOTHERAPY AND CHEST CT SHOWED CORD-LIKE HIGH-DENSITY SHADOW IN THE VASCULAR LUMEN OF AN OUTER BASAL SEGMENT OF THE INFERIOR LOBE IN THE RIGHT LUNG. BASED ON THE CLINICAL SITUATION, RESIDUES OF BROKEN PICC CATHETER WERE CONSIDERED. THE CARDIOTHORACIC SURGERY DEPARTMENT AND THE VASCULAR INTERVENTION DEPARTMENT WERE CONSULTED IMMEDIATELY. THE PICC CATHETER WAS REMOVED ON THE DOCTOR¿S ORDER AND APPROXIMATELY 19.5 CM WAS MISSING FROM THE PROXIMAL CATHETER. DURING RETRIEVAL OF THE RESIDUAL PORTION, THE PATIENT DEVELOPED DISCOMFORTS SUCH AS PALPITATION AND ANHELATION. THE RETRIEVAL WAS CEASED THEREFORE AND FAILED EVENTUALLY. THE RESIDUAL PORTION IS STILL IN THE INFERIOR LOBE OF THE RIGHT LUNG OF THIS PATIENT. EXPERTS¿ CONSULTATION AND TREATMENT ARE AWAITING. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WAS DIAGNOSED WITH ACUTE PROMYELOCYTIC LEUKEMIA AND HAD A GROSHONGPICC CATHETER INSERTED BLINDLY FROM THE LEFT MEDIAN CUBITAL VEIN BY A QUALIFIED PICC PLACEMENT NURSE AT THE HEMATOLOGY DEPARTMENT ON (B)(6), 2022. 48 CM OF THE CATHETER WAS INSERTED INTERNALLY AND ANOTHER 7 CM WAS EXPOSED EXTERNALLY. THE CATHETER TIP WAS POSITIONED IN THE SUPERIOR VENA CAVA. THE PATIENT UNDERWENT CHEMOTHERAPY AND CATHETER MAINTENANCE PERIODICALLY ON THE DOCTOR¿S ORDER, WHEN NO DISCOMFORT SYMPTOMS WERE COMPLAINED OF, SUCH AS CHEST PAIN, CHEST DISTRESS, PALPITATION AND ANHELATION. ON (B)(6), 2023, THE PATIENT WENT BACK HOSPITAL FOR CHEMOTHERAPY AND CHEST CT SHOWED CORD-LIKE HIGH-DENSITY SHADOW IN THE VASCULAR LUMEN OF AN OUTER BASAL SEGMENT OF THE INFERIOR LOBE IN THE RIGHT LUNG. BASED ON THE CLINICAL SITUATION, RESIDUES OF BROKEN PICC CATHETER WERE CONSIDERED. THE CARDIOTHORACIC SURGERY DEPARTMENT AND THE VASCULAR INTERVENTION DEPARTMENT WERE CONSULTED IMMEDIATELY. THE PICC CATHETER WAS REMOVED ON THE DOCTOR¿S ORDER AND APPROXIMATELY 19.5 CM WAS MISSING FROM THE PROXIMAL CATHETER. DURING RETRIEVAL OF THE RESIDUAL PORTION, THE PATIENT DEVELOPED DISCOMFORTS SUCH AS PALPITATION AND ANHELATION. THE RETRIEVAL WAS CEASED THEREFORE AND FAILED EVENTUALLY. THE RESIDUAL PORTION IS STILL IN THE INFERIOR LOBE OF THE RIGHT LUNG OF THIS PATIENT. EXPERTS¿ CONSULTATION AND TREATMENT ARE AWAITING. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13215 GROSHONG 4F SINGLE-LUMEN PICC (60CM) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 NA REEY0888 00801741035326

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention