BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

    MDR report key: 14714498 · Received June 16, 2022

    Report

    Report Number
    3006260740-2022-02290
    Event Type
    Injury
    Date Received
    June 16, 2022
    Date of Event
    May 5, 2022
    Report Date
    July 22, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741035272
    PMA / PMN Number
    K034020
    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

    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 MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REDX0981 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, COMPLAINT AND BATCH HISTORY, APPLICABLE PREVIOUS INVESTIGATION(S), APPLICABLE MANUFACTURING RECORDS, PHOTO AND VIDEO ANALYSIS AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED:THE COMPLAINT OF A COMPLETE BREAK IN THE CATHETER RESULTING IN CATHETER EMBOLIZATION WAS CONFIRMED BUT THE CAUSE IS UNKNOWN. TWO PHOTOS AND A VIDEO WERE RETURNED FOR EVALUATION OF THIS COMPLAINT. THE VIDEO WAS DIFFICULT TO INTERPRET DUE TO FOV AND MOTION. THE PATIENT HAD A NONSPECIFIC CONTRAST OVERLAYING THE RIGHT SHOULDER ON THE FLUOROSCOPIC VIDEO OF THE CHEST. THERE WAS A WIRE OR CATHETER OVERLAYING THE RIGHT PULMONARY ARTERIES. THE RETURNED PHOTOS WERE OF THE IMPLICATED 4FR S/L GROSHONG NXT CATHETER. THE PROXIMAL SEGMENT INCLUDED THE ASSEMBLED TWO-PIECE CONNECTOR AND A SHORT SEGMENT OF THE CATHETER SHAFT. THE DISTAL SEGMENT CONTAINED THE DISTAL PIECE OF THE CATHETER SHAFT. RESIDUAL MATERIAL AND DISCOLORATION WERE SEEN ON THE CATHETER, INDICATING CLINICAL USE. A COMPLETE CIRCUMFERENTIAL BREAK WAS PRESENT IN THE CATHETER SHAFT. HOWEVER, THE PHYSICAL FEATURES OF THE FRACTURE WERE NOT EASILY OBSERVABLE IN THE PROVIDED PHOTOGRAPHS OR VIDEO; THERE WERE NO DISTINGUISHING FEATURES WHICH COULD AID IN IDENTIFICATION OF A SPECIFIC ROOT CAUSE. POSSIBLE CONTRIBUTING FACTORS COULD INCLUDE MATERIAL FATIGUE, SHARP INSTRUMENT DAMAGE, TENSILE (PULLING) DAMAGE, OR OVER-PRESSURIZATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A CATHETER PLACED AFTER GASTRIC CANCER OPERATION AT 4:00 PM, (B)(6) 2021. THE CATHETER WAS INSERTED SUCCESSFULLY, WITH 36 CM PLACED IN THE BODY AND ANOTHER 4 CM EXPOSED EXTERNALLY. X-RAY SHOWED THAT THE TIP OF THE CATHETER WAS POSITIONED AT CAJ. THE PATIENT WAS ADMITTED TO GENERAL SURGERY ON MAY 5, 2022. AFTER COMPLETION OF THE HOSPITAL ADMISSION PROCEDURE, THE PATIENT WENT TO PICC CLINIC TO HAVE THE CATHETER MAINTAINED FOR THERAPY. DURING MAINTENANCE, THE INSERTION SITE WAS EVALUATED ROUTINELY AND NO ABNORMALLY-TORN FILM WAS FOUND. WHEN HOLDING THE EXTERNAL PORTION OF THE CATHETER BY HAND, THE OPERATOR FOUND THAT THE CATHETER WAS RUPTURED INTERNALLY AROUND 2 CM BENEATH THE INSERTION SITE. THE EMERGENCY PLAN FOR INTERNAL CATHETER BREAKAGE WAS INITIATED IMMEDIATELY. X-RAY SHOWED THAT THE LENGTH OF THE INTERNALLY RUPTURED PORTION WAS 35 CM AND THE TIP OF THE CATHETER FLOATED INTO THE ATRIUM. THROUGH MULTIPLE- DISCIPLINE CONSULTATION, THE PORTION WAS REMOVED BY INTERVENTIONAL DEPARTMENT TIMELY. THE PATIENT IS NOT IN LIFE-THREATENING CONDITION AND WAS PACIFIED AND TOLD WITH HEALTH INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD A CATHETER PLACED AFTER GASTRIC CANCER OPERATION AT 4:00 PM, (B)(6) 2021. THE CATHETER WAS INSERTED SUCCESSFULLY, WITH 36 CM PLACED IN THE BODY AND ANOTHER 4 CM EXPOSED EXTERNALLY. X-RAY SHOWED THAT THE TIP OF THE CATHETER WAS POSITIONED AT CAJ. THE PATIENT WAS ADMITTED TO GENERAL SURGERY ON (B)(6) 2022. AFTER COMPLETION OF THE HOSPITAL ADMISSION PROCEDURE, THE PATIENT WENT TO PICC CLINIC TO HAVE THE CATHETER MAINTAINED FOR THERAPY. DURING MAINTENANCE, THE INSERTION SITE WAS EVALUATED ROUTINELY AND NO ABNORMALLY-TORN FILM WAS FOUND. WHEN HOLDING THE EXTERNAL PORTION OF THE CATHETER BY HAND, THE OPERATOR FOUND THAT THE CATHETER WAS RUPTURED INTERNALLY AROUND 2 CM BENEATH THE INSERTION SITE. THE EMERGENCY PLAN FOR INTERNAL CATHETER BREAKAGE WAS INITIATED IMMEDIATELY. X-RAY SHOWED THAT THE LENGTH OF THE INTERNALLY RUPTURED PORTION WAS 35 CM AND THE TIP OF THE CATHETER FLOATED INTO THE ATRIUM. THROUGH MULTIPLE- DISCIPLINE CONSULTATION, THE PORTION WAS REMOVED BY INTERVENTIONAL DEPARTMENT TIMELY. THE PATIENT IS NOT IN LIFE-THREATENING CONDITION AND WAS PACIFIED AND TOLD WITH HEALTH INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118328 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REDX0981 00801741035272

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention