BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT

    MDR report key: 8355205 · Received February 20, 2019

    Report

    Report Number
    3012307300-2019-00869
    Event Type
    Malfunction
    Date Received
    February 20, 2019
    Report Date
    June 26, 2019
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15019315107146
    PMA / PMN Number
    K083031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: ONE USED DECONTAMINATED SAMPLE 007/842/080CZ TUBE & FLANGE ASSEMBLY, CUFFED, UNIPERC, 8MM WAS RECEIVED FOR INVESTIGATION WITHOUT ITS ORIGINAL PACKAGING. UNDER VISUAL INSPECTION THE SAMPLE APPEARED TO BE IN GOOD CONDITION. DURING THE MANUFACTURING PROCESS THE UNIPERC DEVICES ARE 100% INFLATION TESTED, WHICH INCLUDES INFLATING EACH DEVICE CUFF AND LEAVING FOR A 12 HOUR PERIOD. REDUCTIONS IN PRESSURE OVER THIS TIME ARE CONSIDERED A FAILURE AND THE DEVICE WOULD BE REJECTED. THE INFLATION TEST WAS REPEATED ON THE RECEIVED SAMPLE. AFTER 12 HOUR PERIOD THE CUFF WAS SIGNIFICANTLY DEFLATED. THEN THE SAMPLE WAS SUBMERGED IN WATER AND THE TRACHEOSTOMY TUBE CUFF WAS INFLATED USING A SYRINGE FILLED WITH AIR. AIR WAS OBSERVED TO BE LEAKING FROM THE PLACE WHERE INFLATION LINE IS CONNECTED WITH THE INFLATION LUMEN (SEE ATTACHED PHOTO OF DEFECT). REPORTED LEAK WAS CAUSED BY ADJUSTABLE FLANGE WHICH WAS OVER PULLED ABOVE THE LAST MARKING ON THE TUBE WHICH WAS RESULTING TO TEAR OF INFLATION SYSTEM. NO TREND OF CONFIRMED COMPLAINTS IN RELATION WITH THIS ISSUE WAS IDENTIFIED. 30-MAY-2019 ANOTHER SAMPLE RECEIVED: ONE NOT USED UNOPENED BLISTER OF 100/597/000CZ UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT 1/CA LOT 3426553 WAS RECEIVED FOR INVESTIGATION. THIS BLISTER IS PART OF FINISH GOOD PRODUCT WHICH IS IN SCOPE OF THIS COMPLAINT BUT THIS BLISTER DOESN'T CONTAIN ANY TRACHEOSTOMY TUBE WHICH CAN BE INVESTIGATED (NO TRACHEOSTOMY TUBE SHOULD BE THERE AS PER BOM). THEREFORE THIS SECOND SAMPLE HAS NO IMPACT ON INVESTIGATION WHICH HAS BEEN ALREADY PERFORMED. DHR REVIEW SUMMARY:FOLLOWING DHRS WERE REVIEWED: FINISH GOOD WORK ORDER 100/597/080CZ LOT 3379047, MANUFACTURING DATE 2017-03-22, QUANTITY (B)(4); BLISTER SEALING WORK ORDER 007/897/080CZ LOT 3397984, MANUFACTURING DATE 2017-03-21, QUANTITY (B)(4); ASSEMBLY WORK ORDER 007/842/080CZ LOT 3354089 ((B)(4) USED FOR MANUFACTURING OF FINISH GOOD WORK ORDER), MANUFACTURING DATE 2017-01-13, QUANTITY (B)(4); ASSEMBLY WORK ORDER 007/842/080CZ LOT 3365545 ((B)(4) USED FOR MANUFACTURING OF FINISH GOOD WORK ORDER), MANUFACTURING DATE 2017-01-17, QUANTITY (B)(4); ASSEMBLY WORK ORDER 007/842/080CZ LOT 3382159 ((B)(4) USED FOR MANUFACTURING OF FINISH GOOD WORK ORDER), MANUFACTURING DATE 2017-02-17, QUANTITY (B)(4); A REVIEW OF THE DEVICE HISTORY RECORDS SHOWS THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT. THE CUSTOMER REPORTED CONDITION WAS CONFIRMED ROOT CAUSE OF THIS INCIDENT REMAINS UNKNOWN BECAUSE BASED ON INFORMATION WHICH WERE PROVIDED IT IS NOT CLEAR WHEN THE CUFF LEAK WAS OBSERVED - PRIOR USE (IDENTIFIED DURING INFLATION TEST WHICH IS DESCRIBED IN IFU) OR DURING USE (AFTER INFLATION TEST).

    Additional Manufacturer Narrative · 1

    REPORT SOURCE, FOREIGN: (B)(6).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT A ""DIE CUFF" WITHIN A SMITHS MEDICAL PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT LEAKED. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146030 PORTEX UNIPERC PERCUTANEOUS DILATION TRACHEOSTOMY KIT TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. 100/597/080CZ 3379047 15019315107146

    Patients

    Seq Age Sex Outcome Treatment
    1