BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX BLUE LINE ULTRA SUCTIONAID

    MDR report key: 8873851 · Received August 8, 2019

    Report

    Report Number
    3012307300-2019-04014
    Event Type
    Injury
    Date Received
    August 8, 2019
    Date of Event
    July 1, 2019
    Report Date
    September 29, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE USED DECONTAMINATED 007/910/875 7.5MM BLU SUCTIONAID SUB-ASSY 1/EA WAS RECEIVED IN PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION WE NOTICED CUFF TEAR WITH ITS SIZE 1MM SQUARE. DURING MANUFACTURING PROCESS THE DEVICES ARE 100% INFLATION TESTED, WHICH INCLUDES INFLATING EACH DEVICE CUFF AND LEAVING FOR A 12 HOUR PERIOD. REDUCTIONS IN PRESSURE OVER THIS TIME ARE CONSIDERED A FAILURE AND THE DEVICE WOULD BE REJECTED. THE INFLATION TEST WAS REPEATED ON THE RECEIVED SAMPLE. IT WAS OBSERVED THAT IT IS NOT EVEN POSSIBLE TO INFLATE CUFF BECAUSE IT LEAKS SO BADLY. EACH CUFF SHALL BE ALSO TESTED BY CUSTOMER PRIOR USE AS PER INSTRUCTION FOR USE AS10001029-002 REV. 100, PAGE 4, INSTRUCTION FOR USE SECTION, POINT 1: "THE INTEGRITY OF THE CUFF AND INFLATION SYSTEM SHOULD BE CHECKED PRIOR TO INSERTION". DUE TO FACT THAT CUFF LEAK WAS OBSERVED DURING THE USE OF THE PRODUCT IT IS THE MOST PROBABLE THAT REPORTED FAILURE OCCURRED DURING OR AFTER TRACHEOSTOMY PROCEDURE DUE TO CONTACT WITH SHARP EDGE WHICH IS IN CONFLICT WITH INSTRUCTION FOR USE AS10001029-002 REV. 100, PAGE 4, PRECAUTIONS SECTION, POINT 6 "GUARD AGAINST CUFF DAMAGE BY AVOIDING CONTACT WITH SHARP EDGES". THE CUSTOMER REPORTED CONDITION WAS CONFIRMED. PROBLEM SOURCE IS USER INTERFACE.

    Additional Manufacturer Narrative · 1

    FOREIGN (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE ULTRA SUCTIONAID HAD NO ISSUES DURING A PRE-USE CHECK. HOWEVER, WHILE IN USE, THE REPORTER NOTICED THE DEVICE WAS LEAKING AIR. AFTER REMOVING THE TUBE FROM THE PATIENT, THEY FOUND A TEAR IN THE CUFF. THERE WERE NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668176 PORTEX BLUE LINE ULTRA SUCTIONAID TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC. 3778223

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention