BEUDAMED
    FDA Adverse Event Other Summary report: N

    SALTER-STYLE CHILDREN'S CANNULA

    MDR report key: 2494084 · Received February 17, 2012

    Report

    Report Number
    2921601-2012-00004
    Event Type
    Other
    Date Received
    February 17, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 17, 2012
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2012, A NURSE IN THE CHILDREN'S HOSPITAL IN (B)(6) EMAILED SALTER LABS TO INFORM OF AN EVENT INVOLVING SALTER LABS CANNULA TWISTING BEHIND A CHILD'S NECK AS A RESULT OF THE CHILD BEING ACTIVE AND ROLLING AROUND, TWISTING THE CANNULA. ON (B)(4) 2012 A SALTER REPRESENTATIVE WAS ABLE TO SPEAK TO A NURSE AT THE HOSPITAL AND CONFIRM THE PATIENT WAS DOING WELL. THE PRODUCT WAS DISCARDED AND IS UNAVAILABLE FOR RETURN OR ANALYSIS AT SALTER LABS. ADDITIONALLY, THE LOT NUMBER IS NOT KNOWN FOR THE DEVICE, SO THE DEVICE HISTORY RECORD CAN NOT BE REVIEWED FOR THIS PRODUCT. THE HEAD NURSE ASKED THE SALTER REPRESENTATIVE IF THERE WERE ACCESSORY PRODUCTS AVAILABLE THAT CAN KEEP THE CANNULA IN PLACE AND PREVENT TWISTING AS A RESULT OF A LOT OF PHYSICAL MOVEMENT. THE SALTER REPRESENTATIVE WAS ABLE TO LET THE HEAD NURSE KNOW ABOUT PRODUCTS ON THE MARKET (PRODUCED BY SALTER LABS AND OTHER MANUFACTURERS) THAT CAN HELP KEEP A CANNULA IN PLACE. THIS IS A FINAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SALTER-STYLE CHILDREN'S CANNULA PEDIATRIC OXYGEN CANNULA CAT SALTER LABS 1601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention