BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6528523 · Received April 27, 2017

    Report

    Report Number
    3006260740-2017-00535
    Event Type
    Malfunction
    Date Received
    April 27, 2017
    Date of Event
    September 12, 2016
    Report Date
    May 16, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    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, 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 CATHETER BREAK WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE USE RELATED. THE PRODUCT RETURNED FOR EVALUATION WAS A 4FR S/L GROSHONG NXT CLEARVUE PICC WHICH WAS RETURNED IN MULTIPLE PIECES WHICH INCLUDED TWO CATHETER SEGMENTS. A STATLOCK CATHETER SECUREMENT DEVICE WAS ATTACHED TO THE MAIN CATHETER BODY BETWEEN THE 25CM-27CM DEPTH MARKINGS. EXAMINATION OF THE SMALL CATHETER SEGMENT AND MAIN CATHETER SHAFT REVEALED MATCHING BREAK SURFACES WHICH WERE ROUGH AND GRANULAR WITH CONCAVE/CONVEX FEATURES. TACTILE EVALUATION OF THE MAIN CATHETER BODY REVEALED EXTREME TENSILE WEAKNESS PROXIMAL OF THE ATTACHED STATLOCK DEVICE. THE TENSILE WEAKNESS, GRANULAR FRACTURE FEATURES COMBINED WITH CONCAVE/CONVEX PATTERNS WERE ALL CHARACTERISTIC OF A TENSILE BREAK. IT WAS LIKELY THAT THE CATHETER WAS SUBJECTED TO A STRONG PULL BETWEEN THE STATLOCK DEVICE AND CATHETER CONNECTOR WHICH RESULTED IN THE BREAK. NO EVIDENCE OF MANUFACTURE DAMAGE, DEFECT, OR DEFORMITY WAS OBSERVED.

    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 BE EVALUATED. 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 DISCONNECTED FROM THE CATHETER CONNECTOR DURING INFUSION. THE SUTURE WING WAS ATTACHED TO THE STATLOCK AND THE EXTERNAL SECTION OF THE CATHETER WAS STABILIZED BY DRESSING. THE USER ATTEMPTED TO RE-CONNECT CATHETER CONNECTOR AND LOCKSLEEVE BUT EVENTUALLY DISCONNECTED USING FORCEP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER DISCONNECTED FROM THE CATHETER CONNECTOR DURING INFUSION. THE SUTURE WING WAS ATTACHED TO THE STATLOCK AND THE EXTERNAL SECTION OF THE CATHETER WAS STABILIZED BY DRESSING. THE USER ATTEMPTED TO RE-CONNECT CATHETER CONNECTOR AND LOCKSLEEVE BUT EVENTUALLY DISCONNECTED USING FORCEP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310036 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