BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER

    MDR report key: 19731739 · Received July 12, 2024

    Report

    Report Number
    3000219639-2024-00062
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    April 22, 2024
    Report Date
    August 13, 2024
    Manufacturer
    PARKER MEDICAL
    Product Code
    CBI
    UDI-DI
    00607411959493
    PMA / PMN Number
    K092886
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 12 JULY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 12 JULY 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT 09988. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE COMPLAINT REPORTED A "LEAK FOUND AT THE ROOT OF THE BRONCHIAL CUFF." AN INVESTIGATION WAS CONDUCTED BASED ON THE DETAILS PROVIDED, AND IT WAS CONFIRMED THAT NO PATIENT WAS AFFECTED. A SAMPLE WAS RECEIVED, AND THE LEAKAGE WAS CONFIRMED. A LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE DEVICE HISTORY REVIEW COULD NOT BE CONDUCTED. THE ROOT CAUSE COULD NOT BE DETERMINED. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THIS IS THE THIRD COMPLAINT REPORTED FOR PART NUMBER I-PSTDL-37 FOR "LEAKING." THERE WERE SEVEN OTHER COMPLAINTS REPORTED FOR PART NUMBER I-PSTDL-37 DURING THE SAME TIMEFRAME. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Description of Event or Problem · 0

    FOUND LEAK AT ROOT OF BRONCHIAL CUFF.

    Description of Event or Problem · 0

    FOUND LEAK AT ROOT OF BRONCHIAL CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2347167 PARKER PARKER ENDO-BRONCH WITH STANDARD TIP (LEFT DOUBLE-LUMEN ENDOBRONCHIAL TUBE), CBI PARKER MEDICAL H-PSTDL-37 UNKNOWN 00607411959493

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other