BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT NASAL CANNULA

    MDR report key: 3345578 · Received August 22, 2013

    Report

    Report Number
    9680866-2013-00003
    Event Type
    Malfunction
    Date Received
    August 22, 2013
    Date of Event
    July 24, 2013
    Report Date
    July 25, 2013
    Manufacturer
    UNOMEDICAL S.A. DE C.V.
    Product Code
    CAT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT IN USE. BASED ON AVAILABLE INFORMATION, THE RECURRENCE OF THIS MALFUNCTION MAY POSSIBLY LEAD TO A SERIOUS INJURY BECAUSE A DEFORMED/BROKEN/OR EMBEDDED OXYGEN TUBING THAT DOES NOT DELIVER THE OXYGEN A PATIENT REQUIRES CAN JEOPARDIZE STABILITY AND PLACE THE PATIENT INTO A HEMODYNAMICALLY UNSTABLE CONDITION. IT IS EXPECTED THAT THE PRODUCT WITH THE FOREIGN MATTER OR DEFORMITY ON/IN ITS PACKAGING WOULD NOT LIKELY BE USED AS THIS PROBLEM WOULD BE DISCOVERED ON RECEIPT OF THE PRODUCT. THE AFFECTED PRODUCTS WOULD BE EXPECTED TO BE REPLACED. A PRELIMINARY INVESTIGATION, BASED ON THE EXAMINATION OF A PICTURE PROVIDED BY THE CUSTOMER, INDICATED THAT IT IS DIFFICULT TO DETERMINE IF THE PRODUCT MEETS SPECIFICATION. THE ACCEPTANCE CRITERIA FOR CRACKS IN THE INSPECTION (PROCEDURE F802058) STATES THERE IS NO AFFECT ON THE DEVICE FUNCTION; HOWEVER, WITHOUT A COMPLAINT SAMPLE, WE ARE UNABLE TO VERIFY IF THE REPORTED BROKEN COMPONENT AFFECTED THE DEVICE FUNCTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO THE DISTRIBUTOR THAT THEY FOUND SOME COSMETIC ISSUES DURING AN 100% INCOMING INSPECTION. THERE WERE MARKS ON THE CANNULA AS BROKEN, DEFORMATIONS AND EMBEDDED PARTICLES. MORE INFORMATION WAS REQUESTED FROM THE CUSTOMER DUE TO THE UNSPECIFIED SIZE OF THE EMBEDDED PARTICLES AND TO DETERMINE IF THE DEFORMATION AND MARKS HAD AN EFFECT ON THE PRODUCT PERFORMANCE. THE PRODUCT WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    408302 ADULT NASAL CANNULA NASAL OXYGEN CANNULA CAT UNOMEDICAL S.A. DE C.V. H1820 12-34

    Patients

    Seq Age Sex Outcome Treatment
    1