BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STR THOR CATH 36FR

    MDR report key: 5021134 · Received August 21, 2015

    Report

    Report Number
    9612030-2015-00079
    Event Type
    Injury
    Date Received
    August 21, 2015
    Report Date
    August 20, 2015
    Manufacturer
    COVIDIEN
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED BECAUSE A LOT NUMBER WAS NOT PROVIDED. MANUFACTURING RECORDS ARE ROUTINELY REVIEWED PRIOR TO THE RELEASE OF PRODUCT TO ENSURE PROCESS AND PRODUCT COMPLIANCE. A DECONTAMINATED SAMPLE WITHOUT ORIGINAL PACKAGE OR LOT NUMBER WAS RECEIVED FOR EVALUATION. AFTER PERFORMING VISUAL INSPECTION, THE ISSUE WAS OBSERVED, THE SENTINEL EYE WAS IN AN INCORRECT POSITION. AFTER REVIEWING THE MANUFACTURING PROCESS, THE MOST LIKELY ROOT CAUSE OF THE REPORTED CONDITION IS THAT THE POSITIONING OF THE DIE TO PERFORM THE SENTINEL EYE DEPENDS ON THE OPERATOR, AND AN INSPECTION TO REVIEW THE PROPER POSITION OF THE SENTINEL EYE IS NOT REQUIRED DURING THE MANUFACTURING PROCESS. CORRECTIVE ACTION WILL BE THAT THE STANDARD WORK INSTRUCTION (SWI) WILL BE UPDATE TO REQUIRE THE INSPECTION OF THE PROPER POSITION OF THE SENTINEL EYE. AS PREVENTIVE ACTION A SET-UP FOR MANUFACTURING FOR EVERY THORACIC MODEL WILL BE PERFORMED. AN AUTOMATED DIE WILL BE IMPLEMENTED TO AVOID HUMAN ERROR. 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

    AN INVESTIGATION IS CURRENTLY UNDER WAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON 08/20/2015 THAT A CUSTOMER HAD AN ISSUE WITH A CATHETER. THE CUSTOMER STATES 36F COVIDIEN ARGYLE STRAIGHT THORACIC CATHETER WAS PLACED DURING A LEVEL 1 TRAUMA RESUSCITATION FOR PNEUMOTHORAX. THE X-RAY REVEALED THE CATHETER WAS APPROPRIATELY PLACED TOWARDS THE APEX BUT THE SENTINEL HOLE WAS NOT VISIBLE ON MULTIPLE X-RAYS. THE PATIENT HAD INCREASED SUBCUTANEOUS EMPHYSEMA AND THE CHEST TUBE WAS REPLACED. UPON REMOVAL OF THE ORIGINAL TUBE, INSPECTION REVEALED THAT THE LAST HOLE WAS POSITIONED JUST LATERAL TO THE RADIOPAQUE LINE. IT IS UNKNOWN WHAT OTHER FLAWS WERE IN THIS CATHETER, BUT IT WAS NOT THERAPEUTIC AND ADVERSELY AFFECTED THE PATIENT'S CARE LEADING TO ANOTHER INVASIVE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553953 STR THOR CATH 36FR CATHETER KDQ COVIDIEN 8888570564

    Patients

    Seq Age Sex Outcome Treatment
    1 Other