BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 5F INFINITI TL PIG145 110

    MDR report key: 1946292 · Received January 4, 2011

    Report

    Report Number
    9616099-2011-00007
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PHYSICIAN WAS PULLING THE CATHETER OUT FROM THE PACKAGE, THE CATHETER HUB AND STRAIN RELEASE SEPARATED FROM THE CATHETER. THE PRODUCT WAS NOT CLINICALLY USED. ONE NON STERILE 5FR DIAGNOSTIC CATHETER WAS RECEIVED COILED INSIDE A PLASTIC BAG. THE HUB/STRAIN RELIEF WAS RECEIVED SEPARATED FROM THE CATHETER BODY. THE SEPARATION POINT LOOKS ELONGATED AND TRACES OF HUB MATERIAL WERE FOUND ATTACHED TO THE CATHETER BODY. THE CATHETER HUB WAS CROSS SECTIONED AND EVIDENCE OF FUSION BETWEEN THE CATHETER BODY AND THE HUB WERE FOUND. 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 SEPARATION REPORTED BY THE CUSTOMER WAS CONFIRMED. THE CAUSE OF THE SEPARATION COULD NOT BE DETERMINED DURING ANALYSIS. HOWEVER, EVIDENCE OF MATERIAL BOUNDING BETWEEN THE HUB AND THE CATHETER BODY WERE FOUND. NEITHER THE ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE FAILURE EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS. NO CORRECTIVE ACTION WAS TAKEN SINCE THE CAUSE OF THIS FAILURE DOES NOT APPEAR TO BE MANUFACTURING RELATED. ALTHOUGH THE SEPARATION POINT LOOKS ELONGATED AND TRACES OF HUB MATERIAL WERE FOUND ATTACHED TO THE CATHETER BODY AND THE CROSS SECTIONED HUB SHOWED EVIDENCE OF FUSION BETWEEN THE CATHETER BODY AND THE HUB, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Additional Manufacturer Narrative · 1

    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 PRODUCT IS AVAILABLE BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT.ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    AS THE PHYSICIAN WAS PULLING THE F5 PIG TAIL CATHETER OUT FROM THE PACKAGE, THE CATHETER HUB AND STRAIN RELEASED SEPARATED FROM THE CATHETER. THE PRODUCT WAS NOT CLINICALLY USED AND WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH 5F INFINITI TL PIG145 110 DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15271854

    Patients

    Seq Age Sex Outcome Treatment
    1