BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER

    MDR report key: 16924521 · Received May 12, 2023

    Report

    Report Number
    3006260740-2023-01863
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    April 17, 2023
    Report Date
    August 25, 2023
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741086991
    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

    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. BASED ON A REVIEW OF AVAILABLE COMPLAINT INFORMATION AND AN EVALUATION OF THE AVAILABLE SAMPLE EVIDENCE, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A DAMAGED CATHETER WAS CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 4FR S/L GROSHONG CATHETER. THE INVESTIGATION FINDINGS ARE CONSISTENT WITH DAMAGE ACCUMULATED THROUGH FLEXURAL FATIGUE. FLEXURAL FATIGUE OCCURS DUE TO CYCLIC KINKING OF THE CATHETER TUBE IN WHICH PHYSIOLOGICAL, PLACEMENT, USAGE, AND MECHANICAL FACTORS MAY GRADUALLY FORM A CRACK(S) IN THE CATHETER. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A BREAK WAS OBSERVED APPROXIMATELY 4CM FROM THE ASSEMBLED CONNECTOR. THE CATHETER BREAK CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: ¿ DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED ¿ FRACTURE EDGES WHICH WERE ROUNDED AND POLISHED DUE TO REPEATED MATERIAL WEAR ¿ 'C' SHAPED IMPRESSIONS LEADING INTO THE FRACTURE SITE WHICH ARE CONSISTENT WITH MATERIAL BUCKLING DUE TO MOVEMENT WHICH CAUSED THE FRACTURE EDGES TO BE PRESSED TOGETHER ¿ OVERALL ELLIPTICAL SHAPE TO THE FRACTURE CROSS-SECTION (A RESULT OF REPEATED KINKING OF THE TUBING) AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. THE DAMAGE LOCATION SUGGESTED THAT CATHETER SECUREMENT, ACCESS AND MAINTENANCE TECHNIQUES MAY HAVE CONTRIBUTED. H3 OTHER TEXT : EVALUATION FINDINGS ARE IN SECTION H.11.

    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 DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. H3 OTHER TEXT : DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE GROSHONG CATHETER PLACED FROM THE RIGHT BRACHIAL VEIN AT THE HOSPITAL ON (B)(6) 2023. 38 CM OF THE CATHETER WAS INSERTED INTERNALLY, REACHING THE PRECAVA AND ANOTHER 3 CM WAS EXPOSED EXTERNALLY. AFTER DISCHARGE, THE PATIENT HAD THE CATHETER MAINTAINED AT THE HOSPITAL. TWO MONTHS LATER, THE CATHETER WAS FOUND RUPTURED DURING THE 8TH MAINTENANCE AT THE LOCAL HOSPITAL. THE INTERNAL PORTION OF THE CATHETER MOVED NEAR THE LUNG WITH BLOOD FLOW. THE PATIENT GOT BACK TO THE HOSPITAL, WHERE THE RESIDUAL CATHETER WAS REMOVED BY AN EMERGENCY SURGERY AT INTERVENTION DEPARTMENT. GROSHONG CATHETER RUPTURED; PATIENT AND FAMILY QUESTIONED ABOUT THE QUALITY OF THE PRODUCT AND ASKED FOR COMPENSATION. THE CATHETER RUPTURED IN THE PATIENT WITH A FLAT OPENING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD THE GROSHONG CATHETER PLACED FROM THE RIGHT BRACHIAL VEIN AT THE HOSPITAL ON (B)(6) 2023. 38 CM OF THE CATHETER WAS INSERTED INTERNALLY, REACHING THE PRECAVA AND ANOTHER 3 CM WAS EXPOSED EXTERNALLY. AFTER DISCHARGE, THE PATIENT HAD THE CATHETER MAINTAINED AT THE HOSPITAL. TWO MONTHS LATER, THE CATHETER WAS FOUND RUPTURED DURING THE 8TH MAINTENANCE AT THE LOCAL HOSPITAL. THE INTERNAL PORTION OF THE CATHETER MOVED NEAR THE LUNG WITH BLOOD FLOW. THE PATIENT GOT BACK TO THE HOSPITAL, WHERE THE RESIDUAL CATHETER WAS REMOVED BY AN EMERGENCY SURGERY AT INTERVENTION DEPARTMENT. GROSHONG CATHETER RUPTURED; PATIENT AND FAMILY QUESTIONED ABOUT THE QUALITY OF THE PRODUCT AND ASKED FOR COMPENSATION. THE CATHETER RUPTURED IN THE PATIENT WITH A FLAT OPENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357558 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN BASIC TRAY WITH SAFETY INTRODUCER CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 NA REFU3866 00801741086991

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention