BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC ENDOTRACHEAL TUBE

    MDR report key: 4886613 · Received July 1, 2015

    Report

    Report Number
    9611710-2015-00118
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 17, 2015
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BTR
    PMA / PMN Number
    K951697
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED BY A THIRD PARTY. A SAMPLE WAS NOT RECEIVED FROM THE CUSTOMER AT THE MANUFACTURING SITE. ADDITIONAL COMPLAINT INFORMATION WAS RECEIVED FROM THE CUSTOMER DATED 06/24/2015. EMAIL TO THE SALES REPRESENTATIVE FOR ADDITIONAL INFORMATION 06/16/2015. AN EMAIL RESPONSE FROM THE SALES REPRESENTATIVE "FROM WHAT THEY TOLD ME IT (DETACHMENT) HAPPENED AROUND THE SAME TIME OF EXTUBATION. WHEN YOU SEE THE TUBE, IT APPEARS THAT THE PILOT LINE WAS CUT IN THE MIDDLE. POSSIBLY WHEN THE TAPE WAS BEING REMOVED FOR EXTUBATION AND ACCIDENTLY CUT. OF COURSE WE DO NOT KNOW FOR SURE AND NO ONE IS TELLING US ANYTHING, BUT THE LINE WAS INTACT DURING USE UP UNTIL THE END. THE PATIENT WAS NOT INJURED IN ANYWAY AND WEANED CORRECTLY SO WE KNOW THE BALLOON WAS INFLATED DURING USE AT VENTS CHECKS." RETURNED SAMPLE EVALUATION RESULT FOR THE COMPLAINT RECEIVED FROM CUSTOMER DATED 06/30/2015: "THE ET TUBE COMPLAINT SAMPLE WAS WITH THE CLOSED SUCTION CATHETER (CSC) ATTACHED , AS IT WAS IN USE. THE CSC DOES NOT RELATE TO THE REPORTED COMPLAINT, BUT IS PHOTOGRAPHED FOR DOCUMENTATION. THE TWO DEVICES WERE SEPARATED FOR DECONTAMINATION PURPOSES. SAMPLE PHYSICAL APPEARANCE: THERE IS A YELLOWISH BROWN SUBSTANCE AT THE DISTAL END OF THE TUBE. UPON RECEIPT IN THE FAL, THE PILOT LINE WAS DETACHED FROM THE ET TUBE. THE SEVERED ENDS WERE VIEWED UNDER MAGNIFICATION. THE ORIGINAL PACKAGING WAS NOT RETURNED WITH THE DEVICE, THEREFORE THE LOT NUMBER COULD NOT BE VERIFIED." ADDITIONAL INFORMATION FOR THE RETURNED SAMPLE EVALUATION RECEIVED FROM CUSTOMER DATED 07/03/2015 AS FOLLOWS: ON 02 JULY 2015: THE SURFACE EDGES OF THE SEVERED ENDS OF THE INFLATION LINE WERE EXAMINED UNDER MAGNIFICATION. THE SURFACES ARE RELATIVELY SMOOTH, NOT JAGGED AS IF BITTEN. ON ONE END, THE TUBING HAS SOMEWHAT "PINCHED" APPEARANCE, WITH VISIBLE KERF MARKS SEEN. NEITHER LOT NUMBER NOR SAMPLE WAS AVAILABLE TO ASSIST IN OUR INVESTIGATION; THEREFORE RETRIEVAL OF ASSEMBLY RECORD TO SUPPORT THE INVESTIGATION PROCESS WAS NOT POSSIBLE. ONLY THE PRODUCT CODE 35112 WAS AVAILABLE TO ASSIST IN HISTORY. BASED ON PILOT LINE DETACHMENT TEST TRENDING FOR OUTGOING INSPECTION DOES NOT REVEAL ANY SIGN OF DETACHMENT FAILURE. BESIDES THE VISUAL INSPECTION TO MAKE SURE NO NON-GLUED PIECE ESCAPES FOR PILOT BALLOON ASSEMBLY, OUTGOING INSPECTION FOR PILOT LINE DETACHMENT TEST IS PERFORMED BASED ON EACH CUSTOMER ORDER PER EACH PRODUCT CODE. ALL THE SAMPLES MUST BE ABLE TO WITHSTAND FOR 10N DETACHMENT STRENGTH. REVIEW OF THE PILOT LINE DETACHMENT TEST REPORT WITHIN JANUARY 2014 TO MAY 2015 FOR THIS PARTICULAR CODE OF PRODUCT DID NOT REVEAL ANY SIGN OF DETACHMENT FAILURE. THE PILOT LINE DETACHMENT TEST WAS FOUND TO BE WELL WITHIN THE SPECIFICATION DURING THE TESTING. BASED ON THE PICTURE PROVIDED, IT COULD BE OBSERVED THAT THE REMAINING OF THE PILOT LINE STILL INTACT AS THE INFLATION LUMEN. THE EVALUATION SAMPLE DONE BY CUSTOMER HAD MENTIONED THE TUBING HAS A SOMEWHAT "PINCHED" APPEARANCE, WITH VISIBLE KERF MARKS SEEN. THEREFORE, NO FURTHER EVALUATION IS NEEDED AND COMPLAINT CAN BE CONSIDERED CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A (B)(6) OLD INFANT HAD THE ENDOTRACHEAL TUBE (ETT) PLACED PRIOR TO SURGERY. POST-OPERATIVE, THE INFANT WAS TRANSFERRED TO CICU WITH THE ETT IN PLACE. THERE WERE "VENT CHECKS THROUGH THE NIGHT AND ALL WENT WELL". THE NEXT DAY, THE INFANT WAS WEANED FROM THE VENTILATOR AND EXTUBATED, AT THIS TIME, THE STAFF FOUND THE PILOT LINE HAD DETACHED FROM THE ETT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423973 PEDIATRIC ENDOTRACHEAL TUBE TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35112

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO