BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX® THORACIC CATHETERS

    MDR report key: 8822503 · Received July 24, 2019

    Report

    Report Number
    3012307300-2019-02945
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    June 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    PYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURNED WITH INABILITY TO PERFORM INVESTIGATION. HOWEVER, DEFECT WAS CONFIRMED WITH THE PROVIDED PHOTO. RELEVANT DOCUMENTS WERE REVIEWED AND DEEMED ADEQUATE. BASED ON THE INFORMATION PROVIDED THE COMPLAINT WAS CONFIRMED BUT THE ROOT CAUSE FOR THE DEFECT IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING REMOVAL OF A SMITHS MEDICAL PORTEX® THORACIC CATHETER THE TUBING SNAPPED IN HALF. SUBSEQUENTLY, THE PATIENT WAS TAKEN BACK TO SURGERY TO REMOVE THE RETAINED 5 CM OF CHEST TUBING. IT WAS NOTED TO BE FOUND IN THE MEDIASTINUM. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615814 PORTEX® THORACIC CATHETERS THORACIC CATHETER INSERTION TRAY PYI SMITHS MEDICAL ASD; INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention