BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6427997 · Received March 23, 2017

    Report

    Report Number
    3006260740-2017-00286
    Event Type
    Malfunction
    Date Received
    March 23, 2017
    Date of Event
    March 1, 2017
    Report Date
    July 31, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND 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 CATHETER BREAK IS CONFIRMED, USE RELATED. THE PRODUCT RETURNED IS ONE 10 CM SECTION OF 4 FR CATHETER CONSISTENT WITH A GROSHONG NXT CATHETER. USE RESIDUE IS PRESENT AND THE DEPTH MARKINGS ARE HEAVILY WORN. A HOLE IS VISIBLE 5.1 CM FROM THE END EXHIBITING MORE MARKING WEAR. ONE END OF THE CATHETER SECTION APPEARS TO BE CUT WITH A SHARPENED INSTRUMENT. THE OTHER END ALSO APPEARS TO BE CUT WITH A SHARPENED INSTRUMENT. THE INTERIOR SURFACE OF THE BREAK IS VERY JAGGED ON ONE SIDE AND A FINE ROUGH SURFACE ON THE OTHER. TENSILE WEAKNESS IS PRESENT THROUGHOUT THE SECTION WITH WORN MARKINGS. AS THE CATHETER DISPLAYS MULTIPLE SIGNS OF USE AND THE DAMAGE IS CONSISTENT WITH SHARP INSTRUMENT DAMAGE, THE COMPLAINT IS CONFIRMED AS USE RELATED.

    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.

    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 FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, TREND 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 CATHETER BREAK IS CONFIRMED, USE RELATED. THE PRODUCT RETURNED IS ONE 10 CM SECTION OF 4 FR CATHETER CONSISTENT WITH A GROSHONG NXT CATHETER. USE RESIDUE IS PRESENT AND THE DEPTH MARKINGS ARE HEAVILY WORN. A HOLE IS VISIBLE 5.1 CM FROM THE END EXHIBITING MORE MARKING WEAR. ONE END OF THE CATHETER SECTION APPEARS TO BE CUT WITH A SHARPENED INSTRUMENT. THE OTHER END ALSO APPEARS TO BE CUT WITH A SHARPENED INSTRUMENT. THE INTERIOR SURFACE OF THE BREAK IS VERY JAGGED ON ONE SIDE AND A FINE ROUGH SURFACE ON THE OTHER. TENSILE WEAKNESS IS PRESENT THROUGHOUT THE SECTION WITH WORN MARKINGS. AS THE CATHETER DISPLAYS MULTIPLE SIGNS OF USE AND THE DAMAGE IS CONSISTENT WITH SHARP INSTRUMENT DAMAGE, THE COMPLAINT IS CONFIRMED AS USE RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT A CATHETER BREAK WAS FOUND IN THE EXTRACORPOREAL SECTION OF THE CATHETER DURING ROUTINE LINE MANAGEMENT. THE CATHETER WAS CUT SHORT AND IS STILL IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT A CATHETER BREAK WAS FOUND IN THE EXTRACORPOREAL SECTION OF THE CATHETER DURING ROUTINE LINE MANAGEMENT. THE CATHETER WAS CUT SHORT AND IS STILL IN USE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT A CATHETER BREAK WAS FOUND IN THE EXTRACORPOREAL SECTION OF THE CATHETER DURING ROUTINE LINE MANAGEMENT. THE CATHETER WAS CUT SHORT AND IS STILL IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210316 GRO NXT W/STRIPED CATH 4F SL BASIC JPN HANG PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS BARD ACCESS SYSTEMS REAW1546

    Patients

    Seq Age Sex Outcome Treatment
    1