BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

    MDR report key: 3800556 · Received February 11, 2014

    Report

    Report Number
    3006260740-2014-00044
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    December 11, 2013
    Report Date
    December 12, 2013
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A SUBCUTANEOUS BREAK IN THE TUBING IS CONFIRMED, CAUSE UNK. DURING FUNCTIONAL TESTING, THE CATHETER WAS FOUND PATENT TO INFUSION. GROSS AND MICROSCOPIC EXAMINATIONS REVEALED A COMPLETE BREAK IN CATHETER. THE LOCATION OF THE BREAK IS AT APPROX THE MIDDLE PORTION OF THE GROSHONG THREE WAY VALVE SITE. THE CHARACTERISTICS OF THE DAMAGE FOUND ON THE COMPLAINT SAMPLE CONTAIN TRAITS THAT ARE CONSISTENT WITH TENSILE FORCE DAMAGE; HOWEVER THE EXACT MECHANISM OF DAMAGE IS UNK. THE CATHETER TUBING DID NOT EXHIBIT ANY ELONGATION. THE DISTAL SEGMENT THAT CONTAINS THE MANUFACTURED TUNGSTEN PLUG WAS NOT RETURNED FOR EVAL. THE USER INDICATES, "AT THE BEGINNING OF DECEMBER, BLOOD RETURNED HEAVILY IN THE CATHETER." GROSS AND MICROSCOPIC EXAMINATIONS OF THE VALVE CONFIRMS THE DISCOLORATION. THE TUBING APPEARS TO HAVE ABSORBED A CHEMICAL THAT HAS PENETRATED THROUGH THE LUMEN WALL. IN ADDITION TO, THE SHAPE OF THE THREE WAY VALVE IS DISTORTED IN SHAPE. PROBING THE VALVE WITH A YELLOW VEIN PICK AND VIEWING THE ID WALLS SHOWS THE DISCOLORATION HAS PENETRATED THE CLEAR TUBING WALL. THE CAUSE OF THE DISCOLORATION AS WELL AS THE DISTORTION OF THE GROSHONG VALVE IS PRESUMED TO HAVE BEEN CAUSED BY A COMBINATION OF UNK INFUSATES. THE DEGRADED TUBING IS CONCENTRATED AT THE THREE WAY VALVE SITE. IT IS NOT DISTINGUISHABLE WHETHER THE YELLOW STAIN WAS INITIATED FROM INSIDE THE LUMEN OR ABSORBED THROUGH THE OUTSIDE SURFACE. NO INFUSATES WERE LISTED BY THE COMPLAINANT THAT WERE USED WITH THE GROSHONG 4 FR CATHETER. A LOT HISTORY REVIEW (LHR) OF REWG0904 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS PLACED FOR 6 MONTHS, EVERYTHING WENT SMOOTHLY. HOWEVER, AT THE BEGINNING OF DECEMBER, BLOOD RETURNED HEAVILY IN THE CATHETER, ALTHOUGH THE NURSE FLUSHED THE CATHETER REGULARLY, IT STILL HAPPEN. SO FINALLY THE NURSE REMOVED THE CATHETER AND FOUND THE SOMETHING IS WRONG WITH THE VALVE. ADD'L INFO: GROSHONG TIP IS BROKEN OFF RETURNED CATHETER. AFTER CONFIRMED WITH DOCTOR, THER IS NO PIECE OF CATHETER REMAINED IN PT'S BODY BY X-RAY. NO SYMPTOMS THAT MIGHT INDICATE A CATHETER SEGMENT WAS LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90324 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY LJS C.R. BARD, INC. (BASD) REWG0904

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention