BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAGILL SHAPED ETT WITHOUT CUFF W/MURPHY 4.0MM

    MDR report key: 4988485 · Received August 5, 2015

    Report

    Report Number
    9611710-2015-00146
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Report Date
    July 18, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: TO CLARIFY DETAILS OF EVENT DESCRIPTION END USER WAS TRYING TO CONNECT THE ETT SIZE 4.0MM WITH A RESUSCITATION BAG (AS DEPICTED IN THE PHOTO ATTACHED). THIS INFORMATION WAS NOT SUBMITTED ON MDR MANUFACTURER REPORT NUMBER 9611710-2015-00146 (B)(6) 2015. ADDITIONAL INFORMATION: NO SAMPLE WAS RECEIVED FROM THE CUSTOMER, BUT A BATCH REVIEW WAS PERFORMED ON THE LOT NUMBER PROVIDED. THE REVIEW DID NOT REVEAL ANY CONNECTOR DEFECTS. REVIEW OF INCOMING INSPECTION REPORT FOR THE CONNECTOR DID NOT REVEAL ANY SIGN OF DIMENSIONAL FAILURE. IN ADDITION, CONNECTOR ALSO PASSED THE JIG TEST. THE MACHINE END OF THE CONNECTOR WAS FOUND TO TO BE WITHIN SPECIFICATION WHEN MEASURED DURING INCOMING INSPECTION. IN CONCLUSION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT WITHOUT PERFORMING TESTS ON THE PRODUCT AND WITH THE INFORMATION AVAILABLE. THERE IS NOT ENOUGH INFORMATION TO DETERMINE IF THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. NO FURTHER ACTION IS REQUIRED AND THIS COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THERE ARE FOUR (4) CASES ASSOCIATED WITH THIS COMPLAINT; THEREFORE A SEPARATE FDA FORM 3500A HAS BEEN GENERATED TO ADDRESS THE OTHER THREE (3) CASES. REPORTED TO THE FDA ON AUGUST 05, 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SECOND ENDOTRACHEAL TUBE DID NOT FIT FIRMLY INTO THE CONNECTION PORT OF THE RESUSCITATION BAG, ALLOWING THE ENDOTRACHEAL TUBE TO EASILY DISLODGE FROM THE RESUSCITATION BAG. IT WAS REPORTED THE NURSE THEN CONNECTED THE ETT TUBE DIRECTLY TO THE VENTILATOR AND IT WAS ABLE TO CONNECT TO THE VENTILATOR OF THE CONNECTION PORT. IT WAS FURTHER REPORTED NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518847 MAGILL SHAPED ETT WITHOUT CUFF W/MURPHY 4.0MM TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD MM61130040 617431R002

    Patients

    Seq Age Sex Outcome Treatment
    1