BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 5F INFINITI TL 3DRC 100CM

    MDR report key: 3181131 · Received June 21, 2013

    Report

    Report Number
    9616099-2013-00386
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 30, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING. HOWEVER, THE PRODUCT HAS NOT BEEN RETURNED AS OF TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. 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. REVIEW OF LOT 15502751 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM AN AFFILIATE INDICATED THAT A PIECE OF FOREIGN MATTER/HAIR WAS OBSERVED IN THE PACKAGING OF A 5 FR INFINITY 3RDC CATHETER, DURING VISUAL INSPECTION. THE PACKAGING HAD NOT BEEN OPENED. THE PRODUCT WAS NOT CLINICALLY USED IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY AND THE DEVICE WAS RETURNED FOR ANALYSIS. NO PICTURES OF THE DEVICE ARE AVAILABLE. FAL: A NON STERILE COILED DIAGNOSTIC CATH F5 INF 3DRC 100CM AND A CUT PIECE OF PRODUCT ID INNER LABEL WAS RECEIVED INSIDE A SEALED PLASTIC BAG. NO ORIGINAL PACKAGING/POUCH/BOX WAS RECEIVED. NO COMPLAINANT FOREIGN MATERIAL (HAIR) WAS RETURNED FOR ANALYSIS. PER VISUAL ANALYSIS, NO ANOMALIES WERE FOUND ON THE UNIT. 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 REPORTED CUSTOMER COMPLAINT OF FOREIGN MATERIAL COULD NOT BE CONFIRMED THROUGH FAILURE ANALYSIS AS THE DEVICE WAS NOT RETURNED IN ITS ORIGINAL PACKAGING AND NO FOREIGN MATERIAL WAS FOUND ON THE RETURNED PRODUCT. WITH THE INFORMATION PROVIDED AND THE LACK OF FOREIGN MATERIAL WITH THE RETURNED PRODUCT IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NOTHING IN THE DEVICE HISTORY REPORT REVIEW OR THE ANALYSIS TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT INSPECTION OF THE PACKAGING OF THE 100 CM. 5 FR. INFINITY 3DRC DIAGNOSTIC CATHETER REVEALED A PIECE OF FOREIGN MATTER/HAIR INSIDE OF THE STERILE PACKAGING. THE PACKAGING HAD NOT BEEN OPENED. THE PRODUCT WAS NOT CLINICALLY USED IN A PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282127 CATH 5F INFINITI TL 3DRC 100CM DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15502751

    Patients

    Seq Age Sex Outcome Treatment
    1