BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GRO NXT W/STRIPED CATH 4F SL BASIC JPN HANG

    MDR report key: 6765570 · Received August 3, 2017

    Report

    Report Number
    3006260740-2017-01214
    Event Type
    Malfunction
    Date Received
    August 3, 2017
    Date of Event
    July 8, 2017
    Report Date
    August 31, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT OF A LEAK WAS CONFIRMED AND THE CAUSE APPEARS TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 5 FR DUAL LUMEN GROSHONG NXT CATHETER. THE DAMAGE OBSERVED IN THE RETURNED SAMPLE WAS CHARACTERISTIC OF OVER-PRESSURIZATION (BURST) DAMAGE. THIS CAN OCCUR THROUGH THE USE OF SYRINGES SMALLER THAN 10ML, BY FLUSHING AGAINST AN OCCLUSION, OR DUE TO EXCESSIVE FORCE APPLIED DURING INFUSION PROCEDURES. THE RETURNED PRODUCT SAMPLE WAS EVALUATED AND A SPLIT WAS OBSERVED BETWEEN THE 53 CM AND 54 CM DEPTH MARKERS. THIS CATHETER DAMAGE WAS TYPICAL OF A BURST, AND THE CHARACTERISTICS OBSERVED WHICH SUPPORTED THIS TYPE OF FAILURE INCLUDED: 'C' SHAPED SPLIT. TENSILE WEAKNESS AT THE FRACTURE SITE (DUE TO MATERIAL BALLOONING PRIOR TO BURST). GRANULAR FRACTURE SURFACE TEXTURE (TYPICAL OF TEARING FAILURE MODES). THE PRODUCT IFU STATES: ¿DO NOT USE A SYRINGE SMALLER THAN 10 ML.¿

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BARD 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 BARD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LEAKED. THE LEAK WAS IN ITS EXTRACORPOREAL SEGMENT. NO PATIENT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER LEAKED. THE LEAK WAS IN ITS EXTRACORPOREAL SEGMENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542940 GRO NXT W/STRIPED CATH 4F SL BASIC JPN HANG PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1