BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ENDOTRACHEAL TUBES SACETT

    MDR report key: 9753503 · Received February 26, 2020

    Report

    Report Number
    3012307300-2020-01548
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Date of Event
    December 24, 2020
    Report Date
    May 29, 2020
    Manufacturer
    SMITHS MEDICAL ASD, INC
    Product Code
    BTR
    UDI-DI
    15019315059551
    PMA / PMN Number
    K081086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBES SACETT . DEVICE ARRIVED IN ORIGINAL PACKAGE WITH P/N100/189/085 . VISUALLY INSPECTED FROM 12"-24" AND THIS REVEALED SUCTION LINE DETACHED WITH PICTURE PROVIDED. REVIEW WITH QUALITY ENGINEER ON 17/MAR/2020 P/N 100/189/080 L/N 3952513. P/N 100/189/085 AND P/N 100/189/080 BELONGS TO THE SAME PRODUCT FAMILY AND FOLLOWS THE SAME PROCEDURE. THE DEVICE PASSED 100% REVIEW. THE MOST PROBABLE ROOT CAUSE IS THAT THE PRODUCT BECOME DAMAGED AFTER IT LEFT THE SHM FACILITIES DUE TO THE PRODUCT IS 100% VISUAL INSPECTED BY DAMAGE AND 100% FLOW TESTED. NO FAULT CAN BE FOUND WITH DEVICE. AS DEVICE IS MANIPULATED WITH HUMAN CONTACT WITH PRESSURE AGAINST OBJECTS SHARP OR BENT MAY CAUSE EVENT. UPDATED B 1, B 3, B 4, B 5, G 7, H 1, H 2, H 3, H 6 , H 10.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED ON A SMITHS MEDICAL INTUBATION/PORTEX ENDOTRACHEAL TUBE. SUMMARY IN H 10.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NO ANOMALY WAS OBSERVED IN THE PRODUCT AT A PRE-USE CHECK. HOWEVER, 10 DAYS AFTER THE START OF USE, THE SUCTION LINE GOT TORN OFF AT A POINT APPROXIMATELY 2 CM AWAY FROM THE TUBING CONNECTION PART. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220126 PORTEX ENDOTRACHEAL TUBES SACETT TUBE, TRACHEAL (W/WO CONNECTOR) BTR SMITHS MEDICAL ASD, INC 100/189/085 15019315059551

    Patients

    Seq Age Sex Outcome Treatment
    1