BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 11303019 · Received February 9, 2021

    Report

    Report Number
    3012307300-2021-01080
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Date of Event
    January 11, 2021
    Report Date
    May 2, 2023
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE PVC - PORTEX TUBES PDT ULTRAPERC WAS RETURNED FOR ANALYSIS. THE SAMPLE WAS NOT IN THE ORIGINAL PACKAGING AND WAS ACCOMPANIED WITH A CERTIFICATE OF SAFE HANDLING. THE 8MM BLU SUCTIONAID S/ASSY) COMPONENT IS SUPPLIED TO CUMBERNAULD BY SMITHS MEDICAL TIJUANA. ACCORDING TO THE INVESTIGATION, TREND ANALYSIS WAS PERFORMED FOR THE 12-MONTH PERIOD PRIOR TO RECEIPT OF THE CURRENT COMPLAINT WHICH FOUND THAT THERE HAD BEEN TWO PREVIOUS COMPLAINTS RECEIVED FOR KIT 100/563/080 OVER THE 12-MONTH PERIOD. A FURTHER REVIEW WAS PERFORMED ON THESE TWO COMPLAINTS RECEIVED TO IDENTIFY ANY TRENDS AND IT WAS CONFIRMED THAT ONE OF THE COMPLAINTS HAD BEEN RECEIVED FOR ISSUE WITH THE 007/911/880 (8MM BLU SUCTIONAID S/ASSY BULK PACKED) COMPONENT. ACCORDING THE INVESTIGATION, THE ROOT CAUSE OF THE ISSUE EXPERIENCED BY THE CUSTOMER HAS NOT BEEN DETERMINED AND NO CORRECTIVE ACTIONS ARE PLANNED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. ONE (1) SAMPLE WAS RECEIVED IN USED CONDITIONS, WITHOUT ITS ORIGINAL PACKAGING, DECONTAMINATED, INSIDE A PLASTIC BAG. THE RETURNED SAMPLE WAS VISUALLY INSPECTED AT 12IN TO 16IN AND NORMAL CONDITIONS OF ILLUMINATION. PER VISUAL INSPECTION, THE CUFF IS ELONGATED FROM ONE SIDE WHILE DEFLATED. THE CUFF OF THE RETURNED SAMPLE WAS INFLATED USING A SYRINGE WITH AIR AND A DEFORMATION ON THE CUFF WAS OBSERVED. AN AIR BUBBLE CAME OUT OF A TEAR IN THE CUFF. THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE THE MOST PROBABLY ROOT CAUSE WAS THE UNIT BECAME DAMAGED AFTER IT LEFT THE MANUFACTURING FACILITIES. NO CORRECTIVE ACTION WAS REQUIRED SINCE THERE WAS NO INFORMATION TO SUGGEST THAT THE PRODUCT BECOME DAMAGED DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE PORTEX TUBE MALFUNCTIONED. THE CUFF WAS CHECKED PRIOR TO INSERTION WITH NO ISSUES. THE CUFF WAS INITIALLY INFLATED USING A 10ML SYRINGE, THEN PRESSURES CHECKED USING A CUFF MANOMETER. INITIAL CUFF PRESSURES WERE SLIGHTLY HIGH INTENSIVIST RELEASED PRESSURE TO CORRECT LEVEL. AFTER CUFF INFLATION, THE PATIENT WAS NOT ABLE TO BE VENTILATED. THE INTENSIVIST PERFORMED A BRONCHOSCOPY VIA THE TRACHEOSTOMY TUBE AND COULD SEE SOMETHING OBSTRUCTING THE END. THE CUFF WAS DEFLATED AND THEN THE PATIENT WAS ABLE TO BE VENTILATED, THE CUFF WAS RE-INFLATED AND THE SAME THING OCCURRED. THE TRACHEOSTOMY TUBE WAS MANIPULATED, THEN THE CUFF RE-INFLATED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199812 PORTEX TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL, LTD. 100/563/080

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown