BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) YES

    MDR report key: 9715297 · Received February 16, 2020

    Report

    Report Number
    3012307300-2020-01102
    Event Type
    Malfunction
    Date Received
    February 16, 2020
    Date of Event
    December 19, 2019
    Report Date
    March 27, 2020
    Manufacturer
    SMITHS MEDICAL ASD,INC
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ONE TRACHEOSTOMY TUBE WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND THE PILOT BALLOON DETACHED FROM THE TUBE, CONFIRMING THE REPORTED CUSTOMER COMPLAINT. THE MOST PROBABLY ROOT CAUSE HAS BEEN DETERMINED TO BE MANUFACTURING: SOLVENT MISSING BETWEEN PILOT BALLOON AND VALVE, AND A LACK OF DETECTION BY THE PRODUCTION PERSONNEL ON THE LEAK TEST AREA.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) CUFF LINE WAS FOUND TORN. EVENT OCCURED WHEN PATIENT TURNED AND COUGHED, WHILE ALARM NOTIFIED CLINICIAN THE PATIENT VOICE MADE SOUND . NO PATIENT ADVERSE EVENTS, AS PRODUCT WAS NOT USED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178443 TRACHEOSTOMY PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) YES TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL ASD,INC INTUBATION PORTEX ENDOTRACHEAL TUBES SACETT

    Patients

    Seq Age Sex Outcome Treatment
    1