BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX

    MDR report key: 10171363 · Received June 18, 2020

    Report

    Report Number
    3012307300-2020-06067
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    May 14, 2020
    Report Date
    September 28, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    PYI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    RETURNED DEVICE WAS RECEIVED FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE IT COULD BE CONFIRMED THAT THE BLUE FEMALE LUER SHOWS A CRACK. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE IS UNKNOWN THE DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED THAT THIS DEVICE MET ALL MANUFACTURING SPECIFICATION FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX THORACIC CATHETER WAS PUT IN PLACE FOR DRAINAGE OF A RIGHT PLEURAL EFFUSION. THE DRAIN HAD SUCCESSFULLY DRAINED 1200CC OF SEROUS FLUID OVER 12 HOURS. MANIPULATION OF THE DRAIN DRESSING WAS DONE TO ACCESS THE 3-WAY TAP. CONTINUOUS BUBBLING WAS NOTED TO THE DRAINAGE CASE FOLLOWING AND THE TUBING WAS THEN CLAMPED CLOSE TO THE PATIENT. THE BUBBLING CONTINUED, SO THE PATIENT WAS TAKEN TO RADIO CONTROL FOR REMOVAL. AFTER REMOVAL, THE FEMALE CONNECTOR PART WAS NOTED TO HAVE LEAKED AND WAS SPLIT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AS THE EFFUSION WAS OBSERVED TO BE WELL DRAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635429 PORTEX THORACIC CATHETER INSERTION TRAY PYI SMITHS MEDICAL INTERNATIONAL, LTD. 200/910/120 3868498

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R