BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OUTBACK RE-ENTRY CATHETER

    MDR report key: 1161456 · Received September 12, 2008

    Report

    Report Number
    9616099-2008-02223
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    July 21, 2008
    Report Date
    July 21, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K043534
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT REC'D STATES THE OUTBACK LTD CATHETER WAS REC'D IN AN INNER POUCH THAT WAS NOT SEALED. THERE WAS NO PT, VESSEL OR PROCEDURAL INFO PROVIDED. THE PROD WAS REMOVED FROM THE OUTER PACKAGING (THAT WAS INTACT) AND THE OPEN INNER POUCH WAS IDENTIFIED. THE PROD WAS DISCARDED AND ANOTHER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED INJURY FOR THE PT. THE PROD WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MFG DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MFG PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 2113BB REVEALED NO ANOMALIES DURING THE MFG AND INSPECTION PROCESS THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. SIX UNITS WERE REJECTED DURING THE FINAL ASSEMBLY OF THIS LOT. THE DHR REVIEW CONFIRMS THAT THE REJECTED UNITS WERE PROPERLY SEGREGATED AND DISCARDED. NO OTHER ISSUES WERE NOTED THAT WERE CONSIDERED POTENTIALLY RELATED TO THE REPORTED COMPLAINT. REVIEW WAS PERFORMED, WHICH WAS OPENED FOR PROBLEMS IN WELDING PROGRAM ON LASER WELDER #4, QUARANTINE OF MATERIAL WAS PERFORMED AND THE WELDING PROGRAM ON LASER WELDER #4 WAS CORRECTED TO MATCH THE PROGRAM. REVIEW WAS PERFORMED, WHICH WAS OPENED WAS NOT USED AS REQUIRED QUARANTINE OF MATERIAL WAS PERFORMED THE ROOT CAUSE WAS: THE OPERATOR DID NOT FOLLOW INSTRUCTIONS. THE INVESTIGATION SECTION DOES NOT AFFECT THE FUNCTIONAL REQUIREMENTS OF SUBASSEMBLY OR END PROD. WITHOUT THE RETURN OF THE PROD, THE COMPLAINT OF INNER POUCH NOT SEALED COULD NOT BE CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MFG ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. WITH THE LIMITED AMOUNT OF INFO AVAILABLE, IT IS NOT POSSIBLE TO CONCLUDE WHAT MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE SALES REP INDICATED THAT THE PLASTIC SLEEVE ON THE POUCH WAS NOT SEALED. THEREFORE, THE PROD WAS NOT USED. IT WAS NOTED THAT THE BOX WAS SEALED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OUTBACK RE-ENTRY CATHETER CTO CATHETER SYSTEM (DQY) DQY CORDIS DE MEXICO NA 2113BB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK