BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX® ULTRAPERC® SINGLE STAGE DILATOR TECHNIQUE KITS

    MDR report key: 7918077 · Received September 28, 2018

    Report

    Report Number
    3012307300-2018-03909
    Event Type
    Malfunction
    Date Received
    September 28, 2018
    Date of Event
    August 30, 2018
    Report Date
    September 27, 2018
    Manufacturer
    SMITHS MEDICAL ASD; INC.
    Product Code
    KCG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REPORT SOURCE: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE DILATOR TO A SMITHS MEDICAL PORTEX® ULTRAPERC® SINGLE STAGE DILATOR TECHNIQUE KIT BECAME BENT WHILE BEING USED ON A PATIENT. A SECOND KIT WAS USED TO COMPLETE THE TRACHEOSTOMY PROCEDURE. THERE WERE NO REPORTED ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758150 PORTEX® ULTRAPERC® SINGLE STAGE DILATOR TECHNIQUE KITS DILATOR, TRACHEAL KCG SMITHS MEDICAL ASD; INC.

    Patients

    Seq Age Sex Outcome Treatment
    1