BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC ENDOTRACHEAL TUBE (CUFFED)

    MDR report key: 4961432 · Received July 29, 2015

    Report

    Report Number
    9611710-2015-00139
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 7, 2015
    Report Date
    July 10, 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

    A QUALITY COMPLAINT INVESTIGATION WAS PERFORMED BY A THIRD PARTY MANUFACTURER. SAMPLES WERE SENT TO THE THIRD PARTY MANUFACTURER. THE RETURNED SAMPLE EVALUATION RESULT FOR THIS COMPLAINT WAS RECEIVED FROM THE CUSTOMER DATED 07/29/2015: "DATE SAMPLES RECEIVED JULY 22, 2015 FAL RECEIVED ONE USED MICROCUFF ET TUBE WITH NO PACKAGING. THE PRODUCT DOES NOT CONTAIN A LOT NUMBER IDENTIFICATION. RESULTS/COMMENTS: THE INTERIOR OF THE ET TUBE WAS EXAMINED PRIOR TO DECONTAMINATION. NO VISIBLE OBSTRUCTION WAS SEEN. AFTER DECONTAMINATION, THE PROVIDED JMS SUCTION DEVICE WAS INSERTED INTO THE 3.0 MM MICROCUFF ET TUBE. THE SUCTION DEVICE INSERTED FULLY THROUGH THE ET TUBE WITH NO RESISTANCE. A VERIFIED 24 MM (80% OF ET TUBE ID) STEEL BALL WAS INSERTED INTO THE PROXIMAL END OF THE ET TUBE. THE BALL PASS FREELY THROUGH THE ET TUBE WITH NO RESISTANCE. THE REPORTED FAILURE WAS NOT REPRODUCED IN THE LAB. SAMPLE REVIEW COMPLETION DATE JULY 28, 2015." (B)(4) PRODUCTS ARE MANUFACTURED ACCORDING TO PRODUCT SPECIFICATION AND THE PROCESS IS MANUFACTURED ACCORDING TO INTERNAL PROCEDURE OF MANUFACTURED (B)(4) PRODUCT AT THE POINT OF PRODUCT RELEASE. THIS PARTICULAR LOT OF COMPLAINT WAS MANUFACTURED IN MARCH 2015 AND PRODUCED IN (B)(4). THE SHIPMENT FOR THIS LOT IS ON APRIL 2015. REVIEW OF PRIMARY EXTRUSION BATCHES OF THE TUBES USED IN THIS LOT OF PRODUCT DOES NOT REVEAL ANY SIGN OF TUBE DIMENSION FAILURE. THE TUBES ID AND OD MEET THE ESTABLISHED SPECIFICATION DURING PRIMARY PRODUCTION. REVIEWING OF THE BATCH RECORD REVEALED THAT THIS PARTICULAR LOT PASSED THE ENCROACHMENT TEST AS STATED IN PROCESS QUALIFICATION (PQ) WHERE MANDREL COULD PENETRATE THE TUBE INFLATION LUMEN AS WELL AS PIN GAUGE WITH OD OF 2.75 MM AS PER SPECIFICATION WAS USED BY QC PERSONNEL DURING THE STATISTICAL CHECK TO VERIFY THE INSIDE DIAMETER AT PATIENT END (TIP)AS STATED IN PROCESS QUALIFICATION. THIS WAS PERFORMED AND MET REQUIREMENT SPECIFICATION AS NO RESTRICTION WAS ENCOUNTERED WHEN GAUGED. REVIEWING OF THE IN-PROCESS REPORT FOR THE PAST ONE YEAR (2014) DOES NOT REVEAL ANY SIGN OF TUBE BLOCKAGE DETECTED DURING THE INFLATION LUMEN WALL ENCROACHMENT TEST USING 80% STEEL BALL. REVIEW OF THE BATCH RECORD DOES NOT REVEAL ANY SIGN OF ABNORMALITIES. IN ADDITION, THE MANUFACTURING RECORD BASED ON THE LOT NUMBER PROVIDED DID NOT IDENTIFY ANY NON-CONFORMANCE OR ANY OTHER ABNORMALITIES DURING PRODUCTION AND THAT ALL SPECIFICATIONS WERE MET AND DOCUMENTED. BASED ON RECORD REVIEW ALL RELEVANT TESTS PERFORMED DURING MANUFACTURING PROCESS AND FINAL PRODUCT RELEASE HAD BEEN PERFORMED AND MET REQUIREMENT. NO NON-CONFORMITY OF THIS NATURE HAS BEEN REGISTERED DURING THE PRODUCTION OF THIS LOT. WE WILL CONTINUE TO MONITOR THE COMPLAINT TREND TO FIND OUT IF THERE IS ANY OTHER POSSIBLE CAUSE WHICH MAY LEAD TO THIS DEFECT. THEREFORE, NO CORRECTIVE ACTION HAS BEEN IDENTIFIED AS A RESULT OF THIS ANALYSIS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFO, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFO BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE OPERATING ROOM, THE ENDOTRACHEAL TUBE WAS PLACED NASALLY AND "SUCTION OPERATED ABOUT TEN TIME WITHOUT ANY INCIDENT". WHEN THE PT WAS TRANSFERRED TO THE PEDIATRIC INTENSIVE CARE UNIT AND SUCTION WAS BEING PERFORMED, THE PHYSICIAN REPORTED THAT THE SUCTION CATHETER "STUCK ABOUT THE POSITION OF THE CUFF PLACED". IT WAS FURTHER REPORTED THAT THREE DIFFERENT COMPETITOR SUCTION CATHETERS WERE USED AND ALL OF THEM "GOT STUCK". THEY WENT ON TO REPORT THE 'ENDOTRACHEAL TUBE WAS THEN REMOVED FROM THE NOSE AND ANOTHER ENDOTRACHEAL TUBE WAS PLACED ORALLY WITHOUT INCIDENT AND THE PROBLEM WAS RESOLVED.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492378 PEDIATRIC ENDOTRACHEAL TUBE (CUFFED) TUBE, TRACHEAL (W/WO CONNECTOR) BTR UNOMEDICAL SDN BHD 35111 619753R005

    Patients

    Seq Age Sex Outcome Treatment
    1