BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 4092646 · Received August 19, 2014

    Report

    Report Number
    2936999-2014-00776
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 29, 2014
    Report Date
    August 7, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER 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 BROCHOCATH PRODUCTS 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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED STATING, DURING PRIOR TO USE TESTING, THE PHYSICIAN INFLATED THE ENDOBRONCHIAL TUBE CUFF HOWEVER IT DID NOT DEFLATE COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496879 MALLINCKRODT ENDOBRONCHIAL TUBE BTS COVIDIEN 201401394X

    Patients

    Seq Age Sex Outcome Treatment
    1