BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX THORACIC CATHETERS

    MDR report key: 10528755 · Received September 14, 2020

    Report

    Report Number
    3012307300-2020-09257
    Event Type
    Injury
    Date Received
    September 14, 2020
    Date of Event
    July 23, 2020
    Report Date
    February 1, 2021
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    PYI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE DECONTAMINATED 007/910/280 (CATHETER PLEURAL SUB-ASSEMBLY) WAS RETURNED FOR ANALYSIS IN USED CONDITION. VISUAL INSPECTION SHOWED A CRACK ON THE BLUE FEMALE LUER CONNECTOR. THIS CRACK MAY HAVE POTENTIALLY CAUSED THE WHISTLING SOUND AND LEAK. A REVIEW OF MANUFACTURING PROCESSES WAS PERFORMED. IT WAS VERIFIED THAT PROCEDURES IN THE ASSEMBLY PROCESS AND QUALITY CHECK PROCESS WERE BEING PROPERLY FOLLOWED. THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DEFINITELY DETERMINED. ONE POSSIBLE, BUT UNCONFIRMED, PROBLEM SOURCE WAS LISTED AS AN INCOMPATIBILITY OF THE PLEURAL CATHETER WITH COMPONENTS FROM OTHER SUPPLIERS CAUSING THE CRACK DURING THE CONNECTION PROCESS. THE INSTRUCTIONS FOR USE (IFU)WHICH IS SUPPLIED WITH THE SET PROVIDES CLEAR INSTRUCTIONS HOW THE COMPONENTS SHALL BE USED. THE IFU STATES IT IS THE RESPONSIBILITY OF THE USER TO CHECK THE COMPATIBILITY OF THE CHEST DRAINAGE KIT WITH PRODUCTS FROM OTHER SUPPLIERS.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX THORACIC CATHETER WAS INSERTED INTO A PATIENT. AFTER INSERTION, A WHISTLING SOUND WAS HEARD AND EXPELLING OUT OF THE DRAIN. SUBSEQUENTLY, THE DRAIN WAS REMOVED AND REPLACED WITH ANOTHER WITH NO FURTHER ISSUE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994795 PORTEX THORACIC CATHETERS THORACIC CATHETER INSERTION TRAY PYI SMITHS MEDICAL INTERNATIONAL, LTD. 3392633

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R