BEUDAMED
    FDA Adverse Event Other Summary report: N

    VENTR CATH PVC 2 POS LST 18 FR

    MDR report key: 4991193 · Received August 7, 2015

    Report

    Report Number
    1718850-2015-00280
    Event Type
    Other
    Date Received
    August 7, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 10, 2015
    Manufacturer
    SORIN GROUP USA, INC.
    Product Code
    DWF
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE STYLET WAS DIFFICULT TO EXTRACT. THERE WAS NO REPORT OF PATIENT INJURY. THE INVOLVED UNIT WAS DISCARDED, AND THEREFORE NOT RETURNED FOR EVALUATION BUT ANOTHER UNIT FROM THE SAME LOT WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. EVALUATION OF THE RETURNED UNIT WAS ABLE TO REPRODUCE THE ISSUE OF DIFFICULTY REMOVING THE STYLET WHEN TESTED UNDER DRY CONDITIONS BUT ONCE FLUSHED, THE STYLET COULD BE REMOVED WITH NO DIFFICULTY. THE SORIN VENT CATHETER INSTRUCTIONS FOR USE INSTRUCT THE USER TO "REMOVE THE STYLET FROM THE CATHETER AND FLUSH THE CATHETER" PRIOR TO USE. SORIN GROUP INITIATED A CAPA IN RESPONSE TO THIS ISSUE. THE CAPA INVESTIGATION LED TO THE CONCLUSION THAT THE ISSUE WAS CAUSED BY A PROBLEM WITH THE SURFACE FINISH ON THE STYLET. A REVIEW OF THE TUBING SPECIFICATION REVEALED THAT THE SURFACE FINISH DESCRIPTION WAS NOT SPECIFIC ENOUGH TO ENSURE THE FUNCTIONAL REQUIREMENTS WERE MET. THEREFORE THE SPECIFICATION WAS UPDATED TO CALL OUT THE SPECIFIC SURFACE FINISH STANDARD REQUIRED AND THIS UPDATE WAS COMMUNICATED TO THE SUPPLIER OF THE TUBING TO ENSURE PROPER IMPLEMENTATION. NO FURTHER ACTIONS ARE DEEMED NECESSARY AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ON GOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE STYLET WAS DIFFICULT TO EXTRACT. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521247 VENTR CATH PVC 2 POS LST 18 FR CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC. NA 1509200087

    Patients

    Seq Age Sex Outcome Treatment
    1