BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT

    MDR report key: 3001006 · Received February 27, 2013

    Report

    Report Number
    9611710-2013-00187
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Date of Event
    April 11, 2012
    Report Date
    April 16, 2012
    Manufacturer
    UNOMEDICAL SDN BHD
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION HAS BEEN RECEIVED FROM THE ATTENDING SURGEON IN THIS CASE. THE EVENT INVOLVED A FEMALE PATIENT, WEIGHT/HEIGHT (B)(6), (AGE NOT GIVEN), WHOM SURGEONS HAD TROUBLE REMOVING THE ENDOTRACHEAL TUBE DURING EXTUBATION. THE CUFF OF THE ENDOTRACHEAL TUBE WAS COMPLETELY DEFLATED BUT HAD REPORTEDLY FORMED A 6-7 MM HIGH WATTLE-LIKE "WALL" TO THE PROXIMAL END. APPARENTLY THIS "WALL" ON THE CUFF HAD STUCK TO SUBGLOTTIC AIRWAY. THIS NECESSITATED THE SURGEON LOOKING THROUGH A FIBROSCOPE TO OBSERVE THE TRACHEAL SUTURE LINE WHILE THE ENDOTRACHEAL TUBE WAS PULLED OUT WITH EXTRA FORCE. ACCORDING TO THE SURGEON'S CORRESPONDENCE, THE PATIENT HAD SUFFERED A 'SLIGHT LARYNGOSPASM.' THE PROCESS OF EXTUBATION TOOK HALF AN HOUR BUT THE PATIENT'S OXYGENATION STATUS WAS NEVER COMPROMISED AT ANY TIME AND THE PATIENT NEITHER SUSTAINED PHYSICAL INJURIES NOR REQUIRED ANY MEDICAL TREATMENT FOR THE INCIDENCE. BASED ON THE ABOVE, THIS MALFUNCTION IS DEEMED SERIOUS. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE ENDOTRACHEAL TUBE AND THIS EVENT IS DEEMED POSSIBLE. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    THIS COMPLAINT WAS IDENTIFIED DURING OUR RETROSPECTIVE REVIEW OF COMPLAINTS FROM OUR FACILITY IN (B)(6). THIS IS RELATED TO ((B)(4)). THIS COMPLAINT WAS RECEIVED AS FOLLOWS: TUBE IN QUESTION IS MOSTLY MEANT FOR (B)(6) PATIENTS. THE TUBE HAS SEPARATE IRRIGATION AND ASPIRATION CHANNEL FOR RINSING AND VACUUM OF THE TRACHEA ABOVE THE CUFF. PATIENT ((B)(6) FEMALE) WAS INTUBATED WITHIN BLOCK TRANSPORTATION USING AFOREMENTIONED TUBE. GIVEN THE SIZE OF THE PATIENT, SIZE 8 TUBE WAS CONSIDERED APPROPRIATE SIZE DUE TO POST-OP BRONCHOSCOPIES. UPON INSERTION TUBE HAD FELT SLIGHTLY TIGHT. PATIENT WAS DECIDED TO EXTUBATE APPROXIMATELY 20 HOURS POST-OP. CUFF WAS DEFLATED AND TUBE WAS PULLED OUTWARDS. AFTER A FEW CM'S OF FREE MOVEMENT A CONSIDERABLE RESISTANCE WAS FELT AND TUBE COULDN'T BE REMOVED USING NORMAL STRENGTH. PATIENT'S LARYNX LIFTED UPWARDS WITH THE TUBE. EXTUBATION WAS REPEATED WITH THE SAME RESULTS. FIBROSCOPY DID NOT REVEAL THE CAUSE OF THE PROBLEM. WHILE A HEART SURGEON WAS SCOPING THE SOLIDITY OF THE TRACHEAL SEAM, TUBE WAS PULLED OUT BY USING EXTRA FORCE. TRACHEAL SEAM STAYED INTACT. UPON INSPECTION OF THE TUBE IT SEEMED NORMAL AND THE CUFF WAS COMPLETELY DEFLATED. WHEN DEFLATED, CUFF HAD FORMED A 6-7 MM HIGH WATTLE-LIKE "WALL" TO PROXIMAL END. APPARENTLY THIS "WALL" ON THE CUFF HAD STUCK TO SUBGLOTTIC AIRWAY. CUFF MIGHT HAVE PRESSED TOWARDS THE PROXIMAL END IN THE NARROW TRACHEA AND FORMED SAID "WALL" UPON DEFLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83488 ENDOTRACHEAL TUBE - AIRWAY MANAGEMENT TRACHEOBRONCHIAL SUCTION CATHETER BSY UNOMEDICAL SDN BHD MM61114280 609006R001

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention