BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCRODT

    MDR report key: 3983171 · Received July 3, 2014

    Report

    Report Number
    2936999-2014-00610
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 9, 2014
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE BATCH PAPERWORK FOR LOT 201402130X 125037 WAS REVIEWED AND CONFIRMS THAT THE LOT WAS MANUFACTURED TO MEET ALL OF THE BLUEPRINT SPECIFICATIONS AND QUALITY REQUIREMENTS. NO SAMPLE RETURNED FOR EVALUATION. THREE SAMPLES TAKEN FROM STOCK CURRENTLY IN PRODUCTION LOT NUMBER 201409316X PART NUMBER 125039. THE STYLET WIRES WERE REMOVED AND THE SAMPLES WERE INFLATED USING THE PARAMETERS SET OUT IN IF001 AND INFLATED WITHOUT ANY DEFECTS OR RESTRICTIONS NOTED. THE SAMPLES WERE DEFLATED AND NO ISSUES NOTED. THE THREE SAMPLES WERE INFLATED / DEFLATED THREE TIMES AND NO ISSUES NOTED. THE REPORTED DEFECT COULD NOT BE DETECTED ON THE SAMPLES INSPECTED. (B)(4).

    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).

    Description of Event or Problem · 1

    A REPORT FROM (B)(6) STATES THAT BEFORE USING A ENDOBRONCHIAL TUBE THE CUSTOMER CHECKED THE CUFF TO MAKE SURE IT WOULD INFLATE. ONCE THE CUFF WAS BLOWN UP IT WOULD NOT DEFLATE. WHEN THE SALES REP INSPECTED THE PRODUCT DEFLATION WAS DIFFICULT BUT NOT IMPOSSIBLE. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392350 MALLINCRODT BRONCHO CATH LEFT ES 37FR BX1 BTS COVIDIEN 201402130X

    Patients

    Seq Age Sex Outcome Treatment
    1