BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC ENDOTRACHEAL TUBE 3.0MM

    MDR report key: 6074288 · Received November 2, 2016

    Report

    Report Number
    9611710-2016-00147
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    October 13, 2016
    Report Date
    October 19, 2016
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951697
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE BOTH A REPORTABLE MALFUNCTION AND A SERIOUS INJURY. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4). NOTE: THIS COMPLAINT ISSUE OCCURRED IN TWO (2) CASES. A SEPARATE 3500A FORM HAS BEEN PREPARED FOR THE OTHER CASE.

    Additional Manufacturer Narrative · 1

    THE LAST THREE (3) PRODUCT MONITORING REVIEWS (PMRS) WERE REVIEWED. NO TREND WAS OBSERVED FOR THE PRODUCT CATEGORY, ET TUBES, OR THE REPORTED MALFUNCTION, CONNECTOR (INCLUDES SWIVEL CONNECTOR FOR SOME TT MODELS) DETACHED FROM AIRWAY TUBE. COMPLAINT FROM SPANNING (B)(6) 2014 THROUGH (B)(6) 2016 (2 YEARS) WAS REVIEWED AS IT RELATED TO REPORTS FOR THE ET TUBES. A TOTAL OF (B)(4) COMPLAINTS WERE REPORTED. NO TRENDS FOR THE LOT NUMBER, ICC CODE OR FAILURE WERE OBSERVED. NO FURTHER ACTION IS REQUIRED FOR INVESTIGATION OF THIS COMPLAINT. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING THAT A NEONATAL ICU PHYSICIAN INSERTED AN ENDOTRACHEAL TUBE (ETT), SIZE 3.0MM, IN A NEWBORN PATIENT. THE ETT TUBE SHAFT HAD BEEN TRIMMED TO APPROPRIATE LENGTH AND CONNECTED TO THE RED AIRWAY CONNECTOR. THE CONNECTION FAILED AND THE NEWBORN PATIENT RAPIDLY DEVELOPED DYSPNEA. THE ETT WAS REMOVED AND REPLACED AND THE NEWBORN BECAME STABLE. IT WAS ALSO REPORTED THAT "SIMILAR INCIDENTS OF DISCONNECTION AFTER TRIMMING HAVE OCCURRED QUITE FREQUENTLY WITH THE ETT SIZE 3.0MM." IT IS UNKNOWN HOW MANY SIMILAR PRODUCTS HAVE BEEN AFFECTED. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723011 PEDIATRIC ENDOTRACHEAL TUBE 3.0MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61130030 618295R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention