BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 6F INFINITI TL AL III

    MDR report key: 1954390 · Received January 10, 2011

    Report

    Report Number
    9616099-2011-00025
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 9616099-2011-00024. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THE TIP OF SEVERAL INFINITY CATHETERS SEPARATED PRIOR TO USE. PER THE ACCOUNT: THE TIP OF SEVERAL INFINITY DIAGNOSTIC CATHETERS CAME OFF AND THERE ARE AS WELL SEVERAL LITTLE PARTICLES THAT SHOULD BELONG TO THE CATHETERS INSIDE THE PACKAGING. ONE POUCH, ALREADY OPENED, WAS RECEIVED INSIDE OF A SEALED BAG. THE POUCH WAS RECEIVED LABELED AS CATALOG 534647T WITH LOT 13466644. SMALL LOOSE BLUE PARTICLES WERE FOUND INSIDE THE POUCH. THE CATHETER WAS NOT RETURNED FOR ANALYSIS. THE POUCH LABEL WAS FOUND DISCOLORED/YELLOWED. AN FTIR ANALYSIS WAS PERFORMED ON THE BLUE PARTICLES RECEIVED INSIDE THE POUCH. (B)(4) REPORT STATES THAT BLUE PARTICLES FOUND ARE NYLON COMPOSITION (STRAIN RELIEF) IN A DEGRADATION STATE. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT REPORTED WAS CONFIRMED SINCE SEVERAL PARTICLES IN DEGRADATION STATE WERE FOUND INSIDE THE POUCH, BUT THE EXACT CAUSE OF THIS FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. CONTROLS ARE IN PLACE AS 100% INSPECTION PER (B)(4) TO PREVENT THIS TYPE OF FAILURE FROM LEAVING THE FACILITY. HOWEVER, DURING INVESTIGATION IT WAS FOUND THAT SEVERAL COMPLAINTS WERE RECEIVED FROM SAME ACCOUNT EARLY 2010 (1(B)(4)). THE SOURCE OF DEGRADATION COULD NOT BE CONCLUSIVELY DETERMINED AT THAT TIME, BUT MANUFACTURING PROCESS WAS DISCARDED AS POTENTIAL SOURCE OF MATERIAL DEGRADATION. BASED ON AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT COMPLAINT REPORTED WAS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COMPLAINT WAS CONFIRMED ON ANALYSIS. BASED ON AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT COMPLAINT REPORTED WAS RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. REVIEW OF THE INFORMATION DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED FAILURE.

    Description of Event or Problem · 1

    THE TIP OF SEVERAL INFINITY DIAGNOSTIC CATHETERS CAME OFF AND THERE ARE, AS WELL, SEVERAL LITTLE PARTICLES THAT SHOULD BELONG TO THE CATHETERS INSIDE THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH 6F INFINITI TL AL III DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 13466644

    Patients

    Seq Age Sex Outcome Treatment
    1