BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10587688 · Received September 25, 2020

    Report

    Report Number
    3012307300-2020-09823
    Event Type
    Malfunction
    Date Received
    September 25, 2020
    Report Date
    November 23, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    UDI-DI
    15019315106750
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: INVESTIGATION RECEIVED ON A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES PDT ULTRAPERC . THE DEVICE OF UNUSED COMPONENT GOOD KIT 100/562/000CZ IN PLASTIC BAG. UNDER VISUAL INSPECTION, THE COMPONENT FINISH GOOD KIT 100/562/000CZ REVEALED BROKEN AS PHOTO ATTACHED. DURING REPLICATION THE EVENT WAS DUPLICATED AND VERIFIED. THE HYPOTHESIS IS VERY UNLIKELY THE QUIDEWIRE CAUSED EVENT AS THIS IS VERY SOFT. IT IS BELIEVED PROBABLE SOURCE IS DAMAGE DUE TO REINSERTION OF NEEDLE BACK INTO CANNULA. WHEN IT IS DONE WHEN CANNULA IS SLIGHTLY BENT THERE IS RISK THAT TIP OF NEEDLE DAMAGE INSIDE SURFACE OF CANNULA. SUCH REINSERTION IS FORBIDDEN AS PER INSTRUCTIONS FOR USE AS10018928-001 REV. 100 POINT 5.8: "ONCE THE NEEDLE HAS BEEN PARTIALLY OR COMPLETELY WITHDRAWNFROM THE CANNULA, NEVER RE-INSERT IT AS THIS COULD RESULT IN THE CATHETER BEING CUT AND LEFT IN THE TRACHEA." UNFORTUNATELY SUCH SCENARIO CANNOT BE 100% CONFIRMED THEREFORE ROOT CAUSE OF THIS ISSUE REMAINS UNKNOWN.

    Description of Event or Problem · 0

    CUSTOMER STATES THE CANNULA OFTEN KINKS WHEN THEY TRY TO PUT THE GUIDEWIRE THROUGH CANNULA. THE ACTUAL DEVICE HAS NOT BEEN USED ON A PATIENT.

    Description of Event or Problem · 1

    CUSTOMER STATES THE CANNULA OFTEN KINKS WHEN THEY TRY TO PUT THE GUIDEWIRE THROUGH CANNULA. IT WAS REPORTED THE ACTUAL DEVICE HAS NOT BEEN USED ON A PATIENT. BUT WAS ALSO STATED TO HAVE OCCURRED WHILE IN USE WITH A PATIENT. CLARIFICATION HAS BEEN REQUESTED. NO PATIENT INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049339 PORTEX DILATION TRACHY KIT JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/562/000CZ 3980269 15019315106750

    Patients

    Seq Age Sex Outcome Treatment
    1