BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THORACIC TROCAR CATH 28FR SOFT 10/CS

    MDR report key: 5813463 · Received July 21, 2016

    Report

    Report Number
    3004365956-2016-00279
    Event Type
    Malfunction
    Date Received
    July 21, 2016
    Date of Event
    June 6, 2016
    Report Date
    July 7, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    GBX
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED ON 3 SAMPLES OF PRODUCT CODE DTRC-28S WHICH WERE RECEIVED AS PART OF THIS CUSTOMER COMPLAINT, POUCHES ARE CLOSED AND CONTAINS THE COMPLETE COMPONENTS AND THE POUCH WITH ITS LABEL, THE ORIGINAL PACKAGING IS NOT COMPLETE SINCE BOX WAS NOT PRESENT. NO DAMAGES ARE OBSERVED IN THE PIECE. BASED ON THE (B)(4) PRODUCT SPECIFICATION QA-PEV-012 A FUNCTIONAL TESTING IS NOT APPLICABLE SINCE THE MANUFACTURING PROCESS IS ONLY RELATED TO THE CATHETER TIP FORMING. HOWEVER, THE SAMPLE WILL BE SENT TO THE SUPPLIER WHO PERFORMS THE CATHETER MOLDING, PRINTING AND ASSEMBLY PROCESS. CORRECTIVE ACTION CANNOT BE IMPLEMENTED AT THIS TIME SINCE THE PRODUCT COMPLIES WITH THE SPECIFICATION OF TELEFLEX (B)(4), SUPPLIER WILL BE NOTIFIED ABOUT THIS COMPLAINT AND THE SAMPLE WILL BE SENT FOR VISUAL AND FUNCTIONAL VERIFICATION. THE DHR REVIEWED SHOWED THAT THERE WERE NO ISSUES RELATED TO THE REPORTED FAILURE MODE NEITHER ON THE PRODUCT NOR ITS COMPONENTS DURING THE MANUFACTURE OF THIS MATERIAL. HOWEVER, SINCE TELEFLEX (B)(4) DOES NOT PERFORM A FUNCTIONAL TESTING TO THE CATHETER, SAMPLE WILL BE SENT TO THE SUPPLIER OTHER REMARKS: TELEFLEX MEDICAL INC (TECATE) IN ORDER TO EVALUATE IT (VISUAL AND FUNCTIONAL).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HISTORY RECORD OF BATCH NUMBER 74H1401463 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    THE THORACIC TROCAR WAS LEAKING. THEY FIRST NOTICE THE SOUND THAT IT WAS MAKING FROM THE JUNCTION BETWEEN THE TWO CLEAR TUBING. THEY ALSO HAD A CASE WHERE BLOOD WAS COMING OUT OF THAT JUNCTION. THEY TAPED THE LEAK. THERE WERE NO PATIENT ISSUES. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Description of Event or Problem · 1

    THE THORACIC TROCAR WAS LEAKING. THEY FIRST NOTICE THE SOUND THAT IT WAS MAKING FROM THE JUNCTION BETWEEN THE TWO CLEAR TUBING. THEY ALSO HAD A CASE WHERE BLOOD WAS COMING OUT OF THAT JUNCTION. THEY TAPED THE LEAK. THERE WERE NO PATIENT ISSUES. THE PATIENT'S CONDITION WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467537 THORACIC TROCAR CATH 28FR SOFT 10/CS CATHETER,IRRIGATION GBX TELEFLEX MEDICAL 74H1401463

    Patients

    Seq Age Sex Outcome Treatment
    1