BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER FLEX-TIP TRACHEAL TUBE

    MDR report key: 5648434 · Received May 11, 2016

    Report

    Report Number
    1724737-2016-00001
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    December 28, 2015
    Report Date
    May 11, 2016
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS PROVIDED BY PARKER MEDICAL AS MANUFACTURER (B)(4) REGARDING THE MEDWATCH AS FILED BY (B)(6) (01/04/2016). THE DELAY IN TIMING WAS DUE TO A DELAY IN RECEIVING THE FAILED UNITS BACK AT PARKER, AND THE DELAY IN GETTING THE UNITS TO THE CONTRACT MANUFACTURER IN (B)(4). THERE WAS ALSO A DELAY DUE TO AN INTERNAL ERROR AT PARKER, WHICH RESULTED IN THE ISSUANCE OF A CAPA TO ENSURE A MORE ROBUST REPORTING SYSTEM AND REMOVING CHANCE FOR HUMAN ERROR. ADDITIONALLY, PARKER MEDICAL RESPONDED TO THE MEDWATCH FILED WITH A WRITTEN RESPONSE DATED MARCH 13, 2016; HOWEVER, THIS RESPONSE WAS REJECTED BY FDA AND NOW AN ELECTRONIC SUBMISSION IS BEING PROVIDED. A DETAILED LOG OF ALL ACTIVITIES, COMMUNICATIONS, AND EVALUATIONS IS AVAILABLE IN THE PARKER MEDICAL FILE, MDR SECTION. THIS IS THE FIRST MDR FOR THE PARKER MEDICAL PRODUCTS.

    Description of Event or Problem · 1

    THE EVENT WAS ORIGINALLY DESCRIBED IN THE MEDWATCH FORM FILED (UF/IMPORTER # (B)(4)) & MDR REPORT # (B)(4) (FROM MAUDE DATABASE). PLEASE REFERENCE THAT REPORT FOR THE DESCRIPTION OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302800 PARKER FLEX-TIP TRACHEAL TUBE NASAL ENDOTRACHEAL TUBE BTR PARKER MEDICAL 1501NC0101L

    Patients

    Seq Age Sex Outcome Treatment
    1