BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) ST

    MDR report key: 8952046 · Received August 30, 2019

    Report

    Report Number
    3006260740-2019-02569
    Event Type
    Malfunction
    Date Received
    August 30, 2019
    Date of Event
    August 6, 2019
    Report Date
    September 27, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741107894
    PMA / PMN Number
    801(E)
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), AND APPLICABLE FMEA DOCUMENTS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAKING CATHETER WAS CONFIRMED AND THE CAUSE APPEARS TO BE USE RELATED. 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 SPLIT WAS OBSERVED AT THE 43CM DEPHT MARKING. THE CATHETER SPLIT CONTAINED PHYSICAL FEATURES ASSOCIATED WITH MATERIAL FATIGUE, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: DAMAGE WHICH WAS CIRCUMFERENTIALLY ALIGNED. FRACTURE AT THE CORNER OF A KINK IMPRESSION WHICH EXHIBITED POLISH 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 AN EXAMINATION OF THE CATHETER STRUCTURE REVEALED NO POTENTIAL DAMAGE/DEFECT RELATED TO MANUFACTURE OF THE PRODUCT. REFERENCE FAQIR 990179 FOR FURTHER INFORMATION ABOUT THIS FAILURE TYPE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PICC WAS FOUND TO HAVE A HOLE WHEN FLUSHING LIQUID APPEARED. HOSPITAL HAS RECENTLY STARTED USING SECURACATH, THE REP HAS TAUGHT THEM TO PERFORM THE DERMATOTOME DOWN RATHER THAN UP/ACROSS.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF RECZ2080 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC WAS FOUND TO HAVE A HOLE WHEN FLUSHING LIQUID APPEARED. HOSPITAL HAS RECENTLY STARTED USING SECURACATH, THE REP HAS TAUGHT THEM TO PERFORM THE DERMATOTOMY DOWN RATHER THAN UP/ACROSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746164 GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) ST CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A RECZ2080 00801741107894

    Patients

    Seq Age Sex Outcome Treatment
    1