BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCAR CATH 8FR

    MDR report key: 4111207 · Received September 23, 2014

    Report

    Report Number
    9612030-2014-00055
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    DRC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE SEE THE INVESTIGATION SUMMARY BELOW: THE LOT NUMBER WAS PROVIDED AND A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FILE WAS REVIEWED INDICATING THAT PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARD REQUIREMENTS. THERE WERE NO NON-CONFORMING ISSUES REPORTED DURING THE PRODUCTION OF THIS PRODUCT FOR A SIMILAR CONDITION AS REPORTED IN THIS COMPLAINT. A DECONTAMINATED SAMPLE WITHOUT ORIGINAL PACKAGE OR LOT NUMBER WAS RECEIVED FOR EVALUATION AND THE REPORTED ISSUE WAS CONFIRMED. AFTER REVIEWING THE PRODUCTION PROCESS WHERE THE REPORTED CODE IS MANUFACTURED THE ROOT CAUSE IDENTIFIED IS THE VARIATION ON THE NEEDLE HEAD DIAMETERS DIMENSIONS. THREE POINTS WERE MEASURED AND ONE OF THEM WAS DIFFERENT. WHEN THE CATHETER IS MOLDING IT TAKES THE SAME FORM AND VARIATION AS THE DIAMETERS CAUSING THE TROCAR TO BE STUCK ON THE CATHETER WHEN THE DIFFERENT DIAMETERS FROM CATHETER AND TROCAR ARE IN CONTACT. AS A CORRECTIVE ACTION, A QUALITY ALERT WAS POSTED IN INCOMING INSPECTION TO INSPECT (PER ACCEPTABLE QUALITY LEVEL) THE VARIATION PERFORMED ON THE MATERIAL SUPPLIED BY THE VENDOR. A QUALITY ALERT WILL ALSO BE POSTED IN THE PRODUCTION LINE TO NOTIFY APPROPRIATE PERSONNEL REGARDING THE REPORTED CONDITION. THE SUPPLIER WAS NOTIFIED AND THEY PERFORMED AN IMPROVEMENT IN THEIR PROCESS. THEY HAVE CHANGED THE BEARING IN ALL OF THE MANUAL BRITAIN LATHES. IF ADDITIONAL INFORMATION IS RECEIVED WARRANTING FURTHER ANALYSIS, THE INVESTIGATION WILL BE RESUMED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 9/23/2014.AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 1

    THIS INFORMATION WAS INITIALLY PROVIDED BY THE CUSTOMER; HOWEVER, WAS INADVERTENTLY LEFT OF THE INITIAL REPORT FILED ON (B)(6) 2014.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT DURING THE PLACEMENT OF THE CATHETER, THE METAL TROCAR WAS STUCK TO THE PLASTIC TUBE AND THEY WERE UNABLE TO REMOVE THE TROCAR.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A THORACIC CATHETER. THE CUSTOMER REPORTS THE CHEST TUBE THAT WAS ALREADY IMPLANTED IN THE INFANT HAD TO BE SURGICALLY REMOVED SO A NEW 8FR CHEST TUBE COULD BE RE-INSERTED. THE CUSTOMER REPORTS THAT THERE WERE NO ADDITIONAL PROBLEMS WITH THE 2ND TUBE INSERTED. THE CUSTOMER FURTHER REPORTS THAT THE PATIENT WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590018 TROCAR CATH 8FR THORACIC CATHETER DRC COVIDIEN 8888560805 40300664Y

    Patients

    Seq Age Sex Outcome Treatment
    1 Other