BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER

    MDR report key: 6066960 · Received October 31, 2016

    Report

    Report Number
    1718850-2016-00396
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 13, 2016
    Manufacturer
    SORIN GROUP USA, INC
    Product Code
    DWF
    PMA / PMN Number
    K981601
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED DEVICE WAS RETURNED TO SORIN GROUP FOR EVALUATION. VISUAL INSPECTION CONFIRMED THAT THE PLASTIC SHEATH OF THE STYLET WAS LOOSE FROM THE HANDLE, EXPOSING THE INNER METAL WIRE CORE. THE PLASTIC SHEATH APPEARED TO HAVE NOT BEEN CAPTURED BY THE HANDLE MOLDING PROCESS PERFORMED BY AN OUTSIDE SUPPLIER. THE LENGTH OF METAL WIRE AND THE PLASTIC SHEATH OF THE STYLET WERE MEASURED, WHICH FOUND THAT THE PLASTIC SHEATH TOO SHORT. THE PLASTIC SHEATH FOR THIS ASSEMBLY IS CUT TO SIZE BY SORIN MANUFACTURING AND THEN SENT TO THE SUPPLIER FOR THE FINAL ASSEMBLY OF THE HANDLE MOLDING PROCESS. THE SUPPLIER HAS BEEN MADE AWARE OF THIS COMPLAINT AND THE LABORATORY FINDINGS REGARDING THE PLASTIC SHEATH NOT BEING CAPTURED DURING THEIR MOLDING PROCESS. ANY ADDITIONAL FINDINGS WILL BE DOCUMENTED THROUGH THE SORIN SQN SYSTEM. THE SHORT SHEATH WAS CAUSED BY A SORIN MANUFACTURING ERROR. THE INDIVIDUAL RESPONSIBLE FOR THIS STEP IN THE PROCESS WAS IDENTIFIED BASED ON THE REPORTED LOT NUMBER. THE MANUFACTURING DRAWING FOR THIS CATALOG NUMBER WAS REVIEWED, THE POSSIBLE CAUSES FOR THIS ERROR WERE DISCUSSED AND REMEDIAL TRAINING WAS PERFORMED TO ENSURE THAT THE PROPER STEPS NEEDED FOR THIS BUILD WERE CLEARLY UNDERSTOOD. NO TRENDS HAVE BEEN IDENTIFIED FOR THIS TYPE OF ISSUE. SORIN GROUP WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. UNIQUE IDENTIFIER (UDI) NUMBER: (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE METAL SHEATH OF THE MALLEABLE VENT CATHETER CAME OUT DURING BEFORE THE CANNULA WAS PUT INTO THE PATIENT. THE ISSUE OCCURRED TWICE WITH DIFFERENT CANNULA OF THE SAME LOT. THE CANNULA WERE REPLACED FOR THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. ONE OF THE INVOLVED DEVICES WAS SCRAPPED. HOWEVER, THE SECOND DEVICE WAS KEPT AND HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP USA FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. EVALUATION IS IN PROCESS.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT THE METAL SHEATH OF THE MALLEABLE VENT CATHETER CAME OUT DURING BEFORE THE CANNULA WAS PUT INTO THE PATIENT. THE ISSUE OCCURRED TWICE WITH DIFFERENT CANNULA OF THE SAME LOT. THE CANNULA WERE REPLACED FOR THE PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719510 CALIFORNIA MEDICAL LABORATORIES INC MALLEABLE VENT CATHETER CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF SORIN GROUP USA, INC 1618700177

    Patients

    Seq Age Sex Outcome Treatment
    1