BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX THORACIC CATHETERS

    MDR report key: 7815427 · Received August 24, 2018

    Report

    Report Number
    3012307300-2018-03557
    Event Type
    Injury
    Date Received
    August 24, 2018
    Date of Event
    July 27, 2018
    Report Date
    August 24, 2018
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    PYI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL PORTEX¿ THORACIC CATHETER RESISTANCE WAS MET. AS THE DOCTOR PROCEEDED TO PULL OUT THE CATHETER, IT SNAPPED; LEAVING PARTS OF THE CATHETER INSIDE THE PATIENT. SUBSEQUENTLY, THE PATIENT WAS REQUIRED TO GO TO THE OPERATING ROOM (OR) FOR REMOVAL OF THE RETAINED PARTS. THE PATIENT RECOVERED WITH NO FURTHER ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656494 PORTEX THORACIC CATHETERS THORACIC CATHETER INSERTION TRAY PYI SMITHS MEDICAL ASD; INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention