BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10547624 · Received September 17, 2020

    Report

    Report Number
    3012307300-2020-09444
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    August 1, 2020
    Report Date
    November 30, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) . INVESTIGATION WAS DONE ON /N 100/860/070 WITH LOT NUMBER REPORTED UNKNOWN. VISUAL INSPECTION AT RECOMMENDED 12" TO 16" AND NORMAL CONDITIONS OF ILLUMINATION REVEALED NO DISCREPANCIES. DURING FUNCTIONAL TESTING WAS IMMERGED UNDER WATER AND NO LEAKAGE WAS DETECTED AS THE SUCTION LINE OF INFLATION IS STIFFER, HARD BUT DID NOT AFFECT THE FUNCTIONAL OF PRODUCT. QUALITY REVIEW PASSED AND DOCUMENTED AT 100% BEFORE RELEASE OF PRODUCT. NO ACTION AND NO FAULT COULD BE ESTABLISHED AND BELIEVED TO OCCUR AFTER LEAVING SMITHS MANUFACTURING.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION COMPLETED ON A SMITHS TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) . INVESTIGATION WAS DONE ON /N 100/860/070 WITH LOT NUMBER REPORTED UNKNOWN. VISUAL INSPECTION AT RECOMMENDED 12" TO 16" AND NORMAL CONDITIONS OF ILLUMINATION REVEALED NO DISCREPANCIES. DURING FUNCTIONAL TESTING WAS IMMERGED UNDER WATER AND NO LEAKAGE WAS DETECTED AS THE SUCTION LINE OF INFLATION IS STIFFER, HARD BUT DID NOT AFFECT THE FUNCTIONAL OF PRODUCT. QUALITY REVIEW PASSED AND DOCUMENTED AT 100% BEFORE RELEASE OF PRODUCT. NO ACTION AND NO FAULT COULD BE ESTABLISHED AND BELIEVED TO OCCUR AFTER LEAVING SMITHS MANUFACTURING.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

    Description of Event or Problem · 0

    INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) REPORTED MALFUNCTION BY STATING "THE PRODUCT SUCTION LINE TUBE WAS STIFF, AND THE CUSTOMER HAD TROUBLE CONNECTING TO THE PORT, MAKING IT DIFFICULT TO USE. NO PATIENT INJURY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014366 PORTEX TRACHEOSTOMY JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/860/070

    Patients

    Seq Age Sex Outcome Treatment
    1