BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORTEX UNIPERC REPLACEMENT INNER CANNULA

    MDR report key: 19214312 · Received April 30, 2024

    Report

    Report Number
    3012307300-2024-03182
    Event Type
    Injury
    Date Received
    April 30, 2024
    Date of Event
    April 1, 2024
    Report Date
    June 18, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BTO
    UDI-DI
    15019315107177
    PMA / PMN Number
    K083031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED WITH CORRECTIONS: D4. PRIMARY UDI NUMBER: (B)(4). INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: NO PRODUCT SAMPLE WAS RECEIVED; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. INVESTIGATION OF THIS COMPLAINT WAS DONE BASED ON PHOTOS PROVIDED BY CUSTOMER. ON THE PHOTO ARE THE FOLLOWING COMPONENTS: - TUBE & FLANGE ASSEMBLY, CUFFED, UNIPERC, 8MM P/N 007/842/080CZ - INNER CANNULA CLEANING SWAB (SIZE 7, 8, 9) ¿ UNIPERC P/N 005/073/930 - INNER CANNULA - UNIPERC, 8MM P/N 007/522/108 - 8MM BLU THIN WALL INNER CANNULA, P/N 005/073/680 - TRACHY TUBE HOLDER WITH CLEANING BRUSH P/N 005/080/008 THE COMPONENTS 8MM BLU THIN WALL INNER CANNULA, P/N 005/073/680 AND TRACHY TUBE HOLDER WITH CLEANING BRUSH P/N 005/080/008 ARE INCORRECT AS STATED BY THE CUSTOMER. THESE PARTS ARE NOT INCLUDED IN THE PACKAGE OF UNIPERC TUBE. THEY ARE USED FOR A DIFFERENT TYPE OF PRODUCT ¿ FOR BLU TRACHEOSTOMY TUBE. UNIPERC PRODUCTS ARE SOLD TOGETHER WITH CLEANING SWABS 005/073/930. BASED ON ABOVE RATIONALE THIS ISSUE IS CONSIDERED TO BE CAUSED BY HUMAN ERROR DURING USE. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. D4: LOT NUMBER IS UNKNOWN. H3 OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INCIDENT OCCURRED WHEN AN INCORRECT INNER CANNULA CLEANING BRUSH WAS FOUND LODGED IN THE PATIENT¿S LEFT MAIN BRONCHUS AFTER AN EPISODE OF DESATURATION AND ACUTE RESPIRATORY DISTRESS. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131655 PORTEX UNIPERC REPLACEMENT INNER CANNULA TUBE, TRACHEOSTOMY (W/WO CONNECTOR) BTO SMITHS MEDICAL ASD, INC. UNKNOWN 15019315107177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention