BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAM CANNULA

    MDR report key: 3520776 · Received May 23, 2013

    Report

    Report Number
    2025917-2013-00002
    Event Type
    Other
    Date Received
    May 23, 2013
    Date of Event
    October 10, 2012
    Report Date
    April 11, 2013
    Manufacturer
    NEOTECH PRODUCTS, INC.
    Product Code
    CAT
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEPTAL DISCOLORATION APPEARS TO BE DUE TO END USER ERROR. JUDGING FROM THE PT INFO PROVIDED AND THE DEVICE MODEL NUMBER PROVIDED, AN INFANT WAS FITTED WITH A RAM CANNULA DESIGNED FOR NEWBORNS. THIS RULES OUT SEPTAL TRAUMA RESULTING FROM SIZING ERRORS WHERE A LARGER PRONG SIZE THAN IDEAL IS USED. FROM DESCRIPTIONS PROVIDED BY THE END USER, THE INJURY IS DUE TO THE PRONGS BEING INCORRECTLY POSITIONED TOO FAR INTO THE PT'S NARES WHERE THE BASE OF THE CANNULA TUBING IS PRESSED TOO HARD AGAINST THE SEPTUM CAUSING THE SEPTAL TRAUMA. IF THE DEVICE IS PROPERLY POSITIONED, THERE SHOULD BE SOME SPACE BETWEEN THE SEPTUM AND THE BASE OF THE CANNULA.

    Description of Event or Problem · 1

    NEONATE REQUIRED OXYGEN THERAPY VIA NEOTEC PRONGS. TREATMENT WAS INITIATED. DURING ASSESSMENT NEONATE WAS NOTED TO HAVE DISCOLORATION OF SEPTUM OF INFANT NARES. NASAL PRONGS WERE DISCONTINUED AS SOON AS NOTED AND AREA REMAINED SLIGHTLY REDDENED, BUT NO NECROSIS DEVELOPED. PHYSICIAN AWARE AND DISCOLORATION RESOLVED W/O FURTHER INTERVENTION IN APPROX 48 HRS. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PROVISION OF OXYGEN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230878 RAM CANNULA CANNULA, NASAL, OXYGEN CAT NEOTECH PRODUCTS, INC. N4902NS

    Patients

    Seq Age Sex Outcome Treatment
    1 4 MO Other