BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6393063 · Received March 9, 2017

    Report

    Report Number
    3006260740-2017-00216
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    February 13, 2017
    Report Date
    February 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
    NURSE

    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 LEAK IN THE CATHETER WAS CONFIRMED AND THE CAUSE APPEARS TO BE USE RELATED. THE DAMAGE OBSERVED IN THE RETURNED SAMPLE IS CHARACTERISTIC OF OVER-PRESSURIZATION (BURST) DAMAGE. THE PRODUCT RETURNED FOR EVALUATION WAS A 4 FR GROSHONG S/L NXT PICC. THE CATHETER EXHIBITED EVIDENCE OF USE. THE STYLET HAD BEEN REMOVED AND THE TWO PIECE CONNECTOR HAD BEEN ASSEMBLED TO THE 4 FR GROSHONG TUBING. THE CATHETER WAS RECEIVED IN TWO SEGMENTS. THE PROXIMAL CATHETER SEGMENT EXTENDED 6.6 CM FROM THE DISTAL END OF THE STRAIN RELIEF OVERSLEEVE. THE DISTAL CATHETER SEGMENT WAS 41.5 CM IN LENGTH. THE ADJOINING ENDS OF THE CATHETER COINCIDED WITH THE 41 CM DEPTH MARK. THE CATHETER WAS MOST LIKELY SEGMENTED AFTER REMOVAL. THE REPORTED LEAK WAS OBSERVED IN THE PROXIMAL CATHETER SEGMENT. A LONGITUDINAL SPLIT WAS LOCATED NEAR THE 42 CM DEPTH MARK. THE ADJOINING SURFACES OF THE SPLIT WERE NOTED TO BE GRANULAR. A JAGGED CONTOUR WAS OBSERVED IN THE CENTER OF THE SPLIT, WHICH IS CONSISTENT WITH BURST RELATED DAMAGE. A TACTUAL INVESTIGATION REVEALED ELASTIC WEAKNESS IN THE PROXIMAL SEGMENT OF TUBING, WHICH INDICATES THAT THE TUBING WAS STRETCHED DURING USE. RESIDUE FROM WHAT WAS MOST LIKELY A DRESSING REMAINED ADHERED TO THE EXTERNAL SURFACE OF THE PROXIMAL CATHETER SEGMENT. THE DAMAGE OBSERVED ON THE RETURNED CATHETER IS CONSISTENT WITH WEAKENING OF THE TUBING AND OVER-PRESSURIZATION DURING USE. A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE SINCE THE LOT NUMBER WAS NOT PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE FACILITY THAT THE DRUG LEAKED FROM THE CATHETER, 4 DAYS AFTER PLACEMENT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174429 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