BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX SUCTIONPRO 72 SUCTION SYSTEM

    MDR report key: 10171194 · Received June 18, 2020

    Report

    Report Number
    3012307300-2020-06062
    Event Type
    Malfunction
    Date Received
    June 18, 2020
    Date of Event
    March 31, 2020
    Report Date
    August 3, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    PYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE CATHETER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND THE SLIP COLLET TO BE BROKEN. 32 SAMPLES WERE THEN TAKEN FROM THE PRODUCTION FLOOR AND INSPECTED TO VERIFY COMPONENTS WERE UNDAMAGED. NO DISCREPANCIES WERE FOUND. FOUR SAMPLES FROM THE MENTIONED LOT UNDERWENT FUNCTIONAL TESTING BY APPLYING FORCE TO THE SLIP COLLET; NO DISCREPANCIES WERE NOTED. THE REPORTED CUSTOMER COMPLAINT HAS BEEN CONFIRMED AND THE PROBLEM SOURCE HAS BEEN DETERMINED TO BE UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING SUCTIONING A PATIENT WITH A SMITHS MEDICAL PORTEX SUCTION PRO 72 CLOSED SUCTION SYSTEM, THE WHITE PART WAS FOUND BROKEN AND THE SLEEVE CAME OFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635646 PORTEX SUCTIONPRO 72 SUCTION SYSTEM SUCTION CATHETER KIT PYG SMITHS MEDICAL INTERNATIONAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1