BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6337378 · Received February 16, 2017

    Report

    Report Number
    3006260740-2017-00089
    Event Type
    Malfunction
    Date Received
    February 16, 2017
    Date of Event
    January 25, 2017
    Report Date
    January 26, 2017
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    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 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. RESIDUE WAS OBSERVED ON THE CONNECTOR. THE CATHETER EXTENDED 2.2 CM FROM THE DISTAL END OF THE STRAIN RELIEF OVERSLEEVE, WHERE THE CATHETER HAD BEEN CUT. THE CROSS SECTION AT THE DISTAL END OF THE CATHETER SEGMENT REVEALED A SMOOTH, GLOSSY, AND STRIATED SURFACE, WHICH IS CONSISTENT WITH A CUT MADE WITH A SHARP INSTRUMENT. THE DISTAL END OF THE CATHETER WAS NOT RETURNED FOR INVESTIGATION. A LONGITUDINAL SPLIT, WHICH COINCIDED WITH THE DISTAL END OF THE STRAIN RELIEF OVERSLEEVE, WAS OBSERVED IN THE CATHETER. THE ADJOINING SURFACES OF THE SPLIT WERE MICROSCOPICALLY EXAMINED AND WERE NOTED TO BE JAGGED AND GRANULAR. THE CONTOUR OF THE SPLIT BECAME MORE JAGGED TOWARD THE CENTER OF THE SPLIT. THIS TYPE OF DAMAGE IS CONSISTENT WITH OVER PRESSURIZATION. THE PRODUCT IFU STATES, ¿CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OR COMPLETELY OCCLUDED. DO NOT FLUSH AGAINST RESISTANCE. IF THE LUMEN WITH NEITHER FLUSH NOR ASPIRATE AND IT HAS BEEN DETERMINED THAT THE CATHETER IS OCCLUDED WITH BLOOD, A DECLOTTING PROCEDURE PER INSTITUTION PROTOCOL MAY BE APPROPRIATE.¿ 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 A FLUID LEAK WAS OBSERVED AROUND THE OVERSLEEVE. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117704 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