BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDIATRIC ENDOTRACHEAL TUBE(CUFFED)

    MDR report key: 6058623 · Received October 26, 2016

    Report

    Report Number
    9611710-2016-00140
    Event Type
    Injury
    Date Received
    October 26, 2016
    Date of Event
    August 28, 2016
    Report Date
    October 13, 2016
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951697
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE BOTH A SERIOUS INJURY AND A REPORTABLE MALFUNCTION. RESPIRATORY ACIDOSIS IS A MEDICAL EMERGENCY IN WHICH HYPO-VENTILATION INCREASES THE CONCENTRATION OF CARBON DIOXIDE IN THE BLOOD AND DECREASES THE BLOOD'S PH (I.E.: ACIDOSIS). A PHOTOGRAPH HAS BEEN RECEIVED, NO EVALUATION WILL BE CONDUCTED. NO LOT NUMBER IS AVAILABLE. A DETAILED INVESTIGATION OR BATCH REVIEW CANNOT BE CONDUCTED. THEREFORE THIS EVALUATION WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. ADDITIONAL DETAILS HAVE BEEN REQUESTED BUT NOT PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON: OCTOBER 26, 2016. (B)(4).

    Description of Event or Problem · 1

    COMPLAINT REPORTING THAT A (B)(6) PATIENT WITH HISTORY OF HYPOXIC ENCEPHALOPATHY AND TRACHEOSTOMY PRESENTED TO EMERGENCY MEDICAL INTENSIVE CARE (EMICU) UNIT WITH CARDIOPULMONARY ARREST. TREATMENT INCLUDED INTUBATION WITH THE DEVICE ON (B)(6) 2016. THE DEVICE WAS IN PLACE FOR EIGHT (8) DAYS. ON (B)(6) 2016, THE VENTILATOR ALARM RUNG WARNING OF LOW AIRFLOW THRESHOLD AND DECREASED RESPIRATION. CARBON DIOXIDE ACCUMULATED IN THE BODY AND THE PATIENT DEVELOPED LIFE THREATENING RESPIRATORY ACIDOSIS. ATTEMPTED TO INFLATE THE PILOT BALLOON VIA SYRINGE BUT IT DID NOT INFLATE, CONFIRMING LEAKAGE. WATER DROPLETS WERE NOTED INSIDE THE PILOT BALLOON. THE DEVICE WAS REMOVED AND THE PATIENT WAS RE-INTUBATED WITH A DIFFERENT DEVICE. THE PATIENT STATUS RETURNED TO BASELINE WITHOUT ADDITIONAL NEED FOR SUPPLEMENT DOSAGE FOR THE ACIDOSIS. NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708151 PEDIATRIC ENDOTRACHEAL TUBE(CUFFED) TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35115

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Life Threatening| O