BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 6393074 · Received March 9, 2017

    Report

    Report Number
    3006260740-2017-00217
    Event Type
    Malfunction
    Date Received
    March 9, 2017
    Date of Event
    February 16, 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
    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 COMPLAINT OF AN OCCLUDED CATHETER WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE USE RELATED. ONE 4 FR S/L GROSHONG NXT PICC WAS RETURNED FOR INVESTIGATION. THE RETURNED SAMPLE REVEALED EVIDENCE OF USE. THE STYLET HAD BEEN REMOVED AND THE TWO-PIECE CONNECTOR WAS ATTACHED TO THE 4FR S/L TUBING. THE CATHETER EXTENDED 46.3CM FROM THE DISTAL TIP OF THE STRAIN RELIEF OVERSLEEVE. THE 3-POSITION VALVE AND BLACK PLUG WERE PRESENT AT THE DISTAL END OF THE CATHETER. THE DISTAL 38.6CM OF THE CATHETER WAS FILLED WITH A WHITE CRYSTALLINE RESIDUE. A FUNCTIONAL TEST REVEALED THAT THE PICC WAS OCCLUDED. WATER WAS INFUSED INTO THE LUMEN, BUT THE WHITE RESIDUE COULD NOT BE FLUSHED FROM THE CATHETER. THE PRODUCT IFU PROVIDES MAINTENANCE TECHNIQUES TO PREVENT OCCLUSIONS WITHIN THE LUMEN. IT STATES, ¿FOR INTERMITTENT USE, FLUSH THE CATHETER WITH SALINE ONCE EACH WEEK OR AFTER EACH USE. CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OR COMPLETELY OCCLUDED. DO NOT FLUSH AGAINST RESISTANCE. IF THE LUMEN WILL 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 BY THE FACILITY THAT TWO DAYS AFTER PLACEMENT, THE CATHETER WAS COMPLETELY OCCLUDED IN ALL ITS LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176150 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