BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR P.U.R. UMBIL CATH X10

    MDR report key: 4138259 · Received October 3, 2014

    Report

    Report Number
    3009211636-2014-00108
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 17, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 10/03/2014. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS NOT RETURNED; HOWEVER, SIX PHOTOS OF THE CITED CATHETER WERE PROVIDED BY THE COSTUMER. ONE OF PHOTOS SHOWED THE CITED UVC CATHETER WITH A CRACK ON ITS DISTAL END. NO OTHER ISSUE COULD BE IDENTIFIED ON THE OTHER FIVE IMAGES. BASED ON THE EVENT DESCRIPTION, IT CAN BE NOTICED THAT THE USER DID NOT IDENTIFY ANY ISSUE PRIOR TO USE. THE MANUFACTURING LOT NUMBER FOR THE CITED CATHETER WAS 357060 (JULIAN LOT NUMBER 306001X) WHICH WAS RELEASED ON 03/15/2013. THE DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THE REPORTED ISSUE. BASED ON THE PREVIOUS INVESTIGATIONS, IT CAN BE CONCLUDED THAT THE DEVICE WAS MORE LIKELY DAMAGED DURING USE. WITH THE AVAILABLE INFORMATION, THE MOST PROBABLE ROOT CAUSE COULD BE CONSIDERED AS MISUSE (DEVICE COULD BE DAMAGED DUE TO EXCESSIVE FORCE OR A SHARP OBJECT). HOWEVER WITHOUT THE SAMPLE, THIS CANNOT BE CONFIRMED. THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF SPECIAL 510K#K130725. UNDER SPECIAL 510K#K130725, COVIDIEN EXPANDED WARNINGS WITHIN THE INSTRUCTIONS FOR USE MANUAL OF THIS PRODUCT TO HIGHLIGHT THE CONCERN OF UVC CATHETER DAMAGE IN THE HUB AREA ASSOCIATED WITH THE USE OF ALCOHOL BASED DISINFECTANTS. THE INSTRUCTIONS FOR USE WERE REPLACED IN ALL STOCK, AND HOSPITALS WERE SENT A LETTER HIGHLIGHTING THIS ISSUE. IT MUST BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE INSTRUMENTS WITH SHARP OR ROUGH EDGES DIRECTLY ON THE CATHETER AS EVEN A MINOR CUT COULD TEAR OR BREAK THE CATHETER AND CONTINUES, DO NOT PINCH OR BEND THE CATHETER BACK TO TEMPORARILY OCCLUDE THE CATHETER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE UVC WAS CUT AFTER BEING INSTALLED IN THE PATIENT. THE UVC IS LEAKING SOMEWHERE ON THE CATHETER BODY. CHLORHEXIDINE 2% AQUEOUS SOLUTION WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. THE UVC WAS NOT DIFFICULT TO HANDLE DURING INSERTION AND WAS NOT DIFFICULT TO SECURE. WHEN PROCEEDING TO FIX THE UVC WITH A STITCH, IT WAS NOTICED THAT THE CATHETER RUPTURED. THE UVC WAS INSERTED (B)(6) 2014 IN THE UMBILICAL ARTERY. THE UVC WAS IN CONTINUOUS USE. THE UVC WAS CONNECTED TO A VENOUS EXTENSION AND NOTHING WAS USED TO CLEAN THE LINES. THE UVC WAS REMOVED ON (B)(6) 2014 AND REPLACED WITH A NEW DEVICE OF A DIFFERENT LOT. THE PATIENT REMAINED SEVERE DUE TO PREMATURITY. THIS CAUSES INCREASED STRESS ON THE CATHETER WHICH CAN LEAD TO A LEAK OR BREAK. DO NOT USE ALCOHOL, ACETONE, OR ALCOHOL CONTAINING ANTISEPTICS DIRECTLY ON THE CATHETER. CAREFULLY CHECK ANTISEPTIC SOLUTIONS FOR ALCOHOL OR ACETONE. THESE SUBSTANCES MAY CAUSE IRREVERSIBLE DAMAGE TO THE POLYURETHANE WHICH CAN LEAD TO A LEAK OR BREAK. ENSURE GLOVES OR OTHER SURFACES WHICH HAVE ALCOHOL ON THEM ARE COMPLETELY DRY BEFORE TOUCHING OR MANIPULATING THE CATHETER. ALSO UNDER THE SPECIAL 510K#K130725, A DESIGN CHANGE WAS IMPLEMENTED TO INCREASE THE LENGTH OF THE STRAIN RELIEF ON THE LUER HUB OF THE SINGLE LUMEN UVC CATHETERS. THIS CHANGE IS EXPECTED TO REDUCE THE STRESS AND LIKELIHOOD OF KINKING IN THE AREA MOST LIKELY TO BE EXPOSED TO ALCOHOL. THIS CHANGE WAS EXECUTED IN (B)(6) 2014. ADDITIONALLY IN-PROCESS CONTROLS (SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% IN PROCESS VISUAL INSPECTION AND VISUAL ACCEPTANCE SAMPLING) ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. MANUFACTURING PERFORMS 100% LEAK TESTING AT THE FINAL STAGE OF PRODUCTION, WHICH WOULD IDENTIFY THIS ISSUE IN THE CATHETER ASSEMBLY. NO ADDITIONAL CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED FOR THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER (UVC). THE CUSTOMER REPORTS THAT THE UVC WAS INSERTED IN THE UMBILICAL ARTERY AND WAS NOTED TO BE BROKEN AFTER INSERTION. THE CUSTOMER REPORTS THAT A PORTION OF THE CATHETER REMAINED IN THE PATIENT'S ARTERY. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE REST OF THE CATHETER WAS SURGICALLY REMOVED. THE CUSTOMER FURTHER REPORTS THAT THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620160 3.5FR P.U.R. UMBIL CATH X10 UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 306001X

    Patients

    Seq Age Sex Outcome Treatment
    1 Other