BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 4030556 · Received July 14, 2014

    Report

    Report Number
    2936999-2014-00654
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE HAS BEEN RECEIVED FOR INVESTIGATION, CUSTOMER REPORTED ISSUE COULD NOT BE DUPLICATED ON THE SAMPLE RECEIVED. INVESTIGATION EFFORTS FOR CUSTOMER REPORTS OF THE CUFF NOT DEFLATING WERE COMPLETED ON (B)(4) 2014. INVESTIGATION RESULTS REVEALED THE FOLLOWING: INVESTIGATION OF DEFLATION ISSUES ASSOCIATED WITH THE BRONCHOCATH PRODUCT HAS DEMONSTRATED THAT THE POLYURETHANE MATERIAL OF THE TRACHEAL CUFF MAY COLLAPSE IN A NON-SYMMETRICAL MANNER DURING DEFLATION. THIS MAY CREATE A SEAL AROUND THE PERIMETER OF THE NOTCHES IN THE CATHETER, WHICH MAY BLOCK THE PATH FOR AIR EXTRACTION DURING CUFF DEFLATION. ADDITIONALLY, THE INVESTIGATION HAS SHOWN THAT THE DIFFICULTY ASSOCIATED WITH CUFF DEFLATION IS MOST LIKELY TO OCCUR WHEN THE TUBE IS BENT NEAR THE INTERFACE BETWEEN THE NOTCH OPENING AND THE CUFF WALL AND WHEN THE NOTCHED OPENINGS ARE ORIENTED TO THE OUTSIDE OF THE CURVATURE. INFORMATION HAS BEEN ADDED TO THE DATABASE AND TRENDS WILL CONTINUE TO BE MONITORED.

    Additional Manufacturer Narrative · 1

    ONE ENDOBRONCHIAL TUBE WAS RECEIVED BY COVIDIEN. HOWEVER, THE INVESTIGATION HAS NOT YET BEGUN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CUSTOMER IN (B)(6) THAT DURING PRE-TEST OF AN ENDOBRONCHIAL TUBE, THE NURSE OBSERVED THAT THE BALLOON CUFF WOULD NOT DEFLATE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411065 MALLINCKRODT ENDOBRONCHIAL TUBES BTS COVIDIEN 201305451X

    Patients

    Seq Age Sex Outcome Treatment
    1