BEUDAMED
    FDA Adverse Event Summary report: N

    3.5 FR SINGLE LUMEN URETHANE UMBILICAL VESSEL CATHETER

    MDR report key: 2425393 · Received October 24, 2007

    Report

    Report Number
    1317749-2007-00091
    Date Received
    October 24, 2007
    Manufacturer
    TYCO HEALTH CARE/KENDALL
    Product Code
    FOS
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIPT OF THE COMPLAINT SAMPLE CONFIRMED THAT THE CATHETER WAS BROKEN BETWEEN THE 8 AND 9 CM MARKS. THE RETURNED SAMPLE WAS EXAMINED AND MET DIMENSIONAL AND FUNCTIONAL SPECIFICATIONS. AN EXACT MANUFACTURING LOT NUMBER WAS NOT IDENTIFIED IN THE COMPLAINT REPORT THEREFORE A PROPER DEVICE HISTORY REVIEW COULD NOT BE PERFORMED. HOWEVER, SEVERAL POSSIBLE MANUFACTURING LOT NUMBERS WERE PROVIDED BY THE CUSTOMER: 180376, 183518, 704724, 711004, 713109 AND 723613. THERE HAVE BEEN NO PREVIOUS COMPLAINTS RECEIVED FOR ANY OF THESE MANUFACTURING LOTS. IN PROCESS VISUAL, DIMENSIONAL AND FUNCTIONAL TESTING IS PERFORMED ON ALL LOTS OF THIS PRODUCT, INCLUDING TENSILE STRENGTH TESTING. THERE WERE NO QUALITY ISSUES FROM THESE MANUFACTURING LOTS THAT ARE ASSOCIATED WITH THIS COMPLAINT. THIS IS THE FIRST COMPLAINT RECEIVED DURING THE PART 12 MONTHS RELATED TO BREAKAGE OF THE UMBILICAL VESSEL CATHETER. CONCLUSION: BASED ON THE RESULTS OF THIS SAMPLE EVALUATION THIS ISSUE IS NOT CONCLUDED TO BE RELATED TO THE MANUFACTURING OR DESIGN OF THE DEVICE. VISUAL EXAMINATION UNDER MAGNIFICATION INDICATES THAT THE BREAK AREA OF CATHETER IS NARROWER THAN THE REST OF THE CATHETER, WHICH IS CONSISTENT WITH STRETCHING OF THE TUBING. ADDITIONALLY THERE IS EVIDENCE OF SOME TYPE OF RESIDUE ON THE SURFACE OF THE CATHETER, AT THE BROKEN ENDS. IT IS UNCLEAR WHETHER THE CATHETER WAS CUT BY A SHARP INSTRUMENT IN THIS AREA DURING HANDLING AND MAINTENANCE BY THE CUSTOMER OR IF THE CATHETER WAS CUT BY A SHARP INSTRUMENT IN THIS AREA DURING CATHETER INSERTION AND MAINTENANCE. IF THE CATHETER WAS SUTURED TOO TIGHT, THIS COULD WEAKEN OR ACTUALLY CUT INTO THE CATHETER AND EVENTUALLY CONTRIBUTE TO A BREAK. THE INSTRUCTIONS FOR USE THAT ARE PACKAGED WITH THIS PRODUCT INDICATE THE FOLLOWING PRECAUTION # 7: EXERCISE CAUTION WHEN SUTURING CATHETER TO AVOID CUTTING, INDENTING OR COMPROMISING THE CATHETER IN ANY WAY. BASED ON THE COMPLAINT INCIDENCE RATE, NO TRENDING IS EVIDENT. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 1

    YOUR COMPLAINT CONCERNING OUR 3.5FR URETHANE UMB CATH WAS REVIEWED BY OUR QUALITY ASSURANCE DEPARTMENT. THE CUSTOMER COMPLAINT INVOLVED PRODUCT NUMBER 8888160333, 3.5 FR SINGLE LUMEN URETHANE BN UMBILICAL VESSEL CATHETER. THE COMPLAINT SAMPLE WAS RETURNED AND RECEIVED ON 09/20/2007. THE 3.5 SINGLE LUMEN URETHANE UMBILICAL VESSEL CATHETER WAS RECEIVED IN TWO (2) PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5 FR SINGLE LUMEN URETHANE UMBILICAL VESSEL CATHETER UMBILICAL VESSEL CATHETER FOS FOS TYCO HEALTH CARE/KENDALL

    Patients

    Seq Age Sex Outcome Treatment
    1