BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10198082 · Received June 25, 2020

    Report

    Report Number
    3012307300-2020-06253
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    May 1, 2020
    Report Date
    July 30, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    JOH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    SMJ#CFFK013. DURING THE USE OF THE PRODUCT WITH AN ARTIFICIAL RESPIRATOR, LEAKAGE OF AIR WAS DETECTED. AFTER REMOVING THE PRODUCT FROM THE PATIENT, WHEN THEY CHECKED IT, IT LOOKED LIKE THE PRODUCT HAD A PINHOLE IN IT. NO PATIENT INJURY. ADDITIONAL INFORMATION. PSR: WILL THE PRODUCT BE RETURNING TO SMITHS MEDICAL? YES. ? DATE OF THE EVENT: END OF MAY. ? DID THE PRODUCT ISSUE CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY? NO ADVERSE EVENT OCCURRED. O IF YES, WAS ANY MEDICAL INTERVENTION PROVIDED? PLEASE EXPLAIN. ? PATIENT INFORMATION - NO INFORMATION. O INITIALS O DATE OF BIRTH O GENDER O WEIGHT O ETHNICITY O RACE ? RELEVANT TESTS/LABORATORY DATA INCLUDING DATES PSR :. ? OTHER RELEVANT HISTORY, INCLUDING PRE-EXISTING CONDITIONS . ? DID THE PATIENT RECEIVE MEDICAL TREATMENT (ANYTHING THAT IS NOT OVER-THE-COUNTER)? NO ADVERSE EVENT OCCURED. O IF SO, WHAT? O PLEASE INCLUDE RELEVANT TESTS/LABORATORY DATE (INCLUDING DATES) ? WHAT IS THE OUTCOME OF THE EVENT? RESOLVED. O RESOLVED O ONGOING. ? CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF A SMITHS MEDICAL PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE, LEAKAGE OF AIR WAS DETECTED. THE PATIENT WAS REPORTED TO BE ON A RESPIRATOR AND REQUIRED THE TUBE TO BE REMOVED FROM THE PATIENT. A PINHOLE WAS FOUND ON THE TUBE FOLLOWING REMOVAL. THERE WAS NO PATIENT INJURY AND NO ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657464 PORTEX TUBE TRACHEOSTOMY AND TUBE CUFF JOH SMITHS MEDICAL INTERNATIONAL, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention