BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MALLINCKRODT

    MDR report key: 3853146 · Received April 2, 2014

    Report

    Report Number
    2936999-2014-00311
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 14, 2025
    Manufacturer
    COVIDIEN
    Product Code
    BTS
    PMA / PMN Number
    K771219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE ASSOCIATED TO THIS REPORT IS EXPECTED TO BE RETURNED FOR ANALYSIS. IF THE SAMPLE IS RECEIVED, A SUMMARY OF THE INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    ONE ENDOBRONCHIAL TUBE SAMPLE WAS RETURNED FOR EVALUATION CONTAINED IN ITS ORIGINAL OPEN UNIT PACK. VISUAL EXAMINATION SHOWED NO SIGNS OF ANY DEFECT, AND THE STYLET WIRE HAS NOT BEEN RETURNED WITH THE SAMPLE. BOTH CUFFS ON THE RETURNED SAMPLE WERE INFLATED USING THE PARAMETERS SET OUT, AND INFLATED WITHOUT ANY DEFECTS OR RESTRICTIONS NOTED. THE CUFFS WERE DEFLATED WITH NO ISSUES NOTED. THE RETURNED UNIT WAS INFLATED /DEFLATED THREE TIMES, AND NO ISSUES WERE NOTED. THE REPORTED DEFECT COULD NOT BE DETECTED ON THE SAMPLE RETURNED FOR EVALUATION. ALL OF OUR BRONCHO CATHETERS PRODUCTS UNDERGO A FOUR HOUR INFLATE/DEFLATE TEST PRIOR TO RELEASE FROM OUR MANUFACTURING FACILITY, AND IT IS AT THIS STAGE IN THE PROCESS THAT ANY DEFECTS ARE REMOVED FROM THE LOT. THE DEVICE HISTORY REVIEW (DHR) PERFORMED FOR LOT 201305371X WAS REVIEWED, AND CONFIRMED THAT THE LOT WAS MANUFACTURED TO MEET ALL OF THE BLUEPRINT SPECIFICATIONS AND QUALITY REQUIREMENTS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTS: DURING THE CUFF BALLOON TEST BEFORE USE, THE CUFF DID NOT DEFLATE. THERE WAS NO PT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199955 MALLINCKRODT ENDOBRONCHIAL TUBE LEFT/RIGHT BTS COVIDIEN 201305371X

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female