BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE

    MDR report key: 7332618 · Received March 12, 2018

    Report

    Report Number
    3012307300-2018-00440
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 26, 2018
    Report Date
    July 3, 2018
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PART NUMBER: CORRECT PART NUMBER: 100/517/080, WRONG PART NUMBER: 100/517/070.

    Additional Manufacturer Narrative · 1

    (B)(6)

    Additional Manufacturer Narrative · 1

    ONE VOCALAID 8.00MM TRACHEOSTOMY TUBE WAS RECEIVED FOR ANALYSIS IN USED CONDITION. THE CUSTOMER'S REPORTED PROBLEM WAS "ONLY WHEN THE PRODUCT WAS INSERTED INTO A PATIENT, IT DEFLATED". THE SAMPLE WAS VISUALLY INSPECTED AT A DISTANCE OF 12" TO 16" UNDER NORMAL CONDITIONS OF ILLUMINATION. NO DISCREPANCIES WERE FOUND. A SYRINGE WAS USED TO INFLATE THE CUFF AND PILOT TUBE AND SUBMERGED UNDER WATER IN ORDER TO DETECT ANY LEAKS. NO LEAKS WERE DETECTED. THE CUFF DIDN'T DEFLATE DURING ONE HOUR THAT IT WAS INFLATED. THE MANUFACTURING AND QUALITY INSPECTION PROCESSES WERE REVIEWED AND CONSIDERED ADEQUATE AND CORRECT. THE REPORTED PROBLEM WAS NOT CONFIRMED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE CUFF DEFLATED TO A SMITHS MEDICAL PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE UPON INSERTION INTO A PATIENT. TUBE REPLACEMENT WAS REQUIRED. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174317 PORTEX® CUFFED BLUE LINE ULTRA® TRACHEOSTOMY TUBE TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1