BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER

    MDR report key: 21944364 · Received May 1, 2025

    Report

    Report Number
    3000219639-2025-00043
    Event Type
    Injury
    Date Received
    May 1, 2025
    Date of Event
    March 15, 2025
    Report Date
    May 1, 2025
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 01 MAY 2025 HAS BEEN INCLUDED IN THE 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 IS 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 A AIRLIFE PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. THE INVESTIGATION WAS COMPLETED BEFORE THE DUE DATE OF THE INITIAL REPORT SO THE INITIAL AND FINAL REPORT ARE BEING SUBMITTED AT THE SAME TIME. RESULTS FROM THE INVESTIGATION ARE AS FOLLOWS: COMPLAINT WAS CONSIDERED CONFIRMED BASED ON CUSTOMER NARRATIVE OF EVENTS HOWEVER IT WAS DETERMINED THAT THE INCIDENT DID NOT OCCUR DUE TO THE DEVICE. A 24 MONTH REVIEW WAS CONDUCTED AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED RELATED TO THIS ISSUE. THE LOT NUMBER WAS NOT PROVIDED, AND THE VENDOR WAS NOTIFIED OF THE INCIDENT. THIS INCIDENT WAS NOT IDENTIFIED AS AN INCREASING TREND. NO FURTHER ACTION TO BE TAKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS INTUBATED 1 CM DEEPER THAN EXPECTED., SO THE CUFF WAS CONTRACTED BY 10 CC AND SLID SLIGHTLY IN THE FOREFRONT. SUBCUTANEOUS HEMATOMA WAS FOUND. CONFIRMED 4 CM LACERATION AT TRACHEAL BIFURCATION. X-RAY CONFIRMED THAT THE PATIENT WAS INTUBATED 1 CM DEEPER THAN EXPECTED., SO THE CUFF WAS CONTRACTED BY 10 CC AND SLID SLIGHTLY IN THE FOREFRONT. BLOOD SPUTUM WAS CONFIRMED BY THE PATIENT. BRONCHOSCOPE INSERTED INTO PATIENT. SUBCUTANEOUS HEMATOMA WAS FOUND. CONFIRMED 4 CM LACERATION AT TRACHEAL BIFURCATION. BLOOD WAS FOUND ON THE EXTUBATED TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189220 PARKER TRACH-VAC WITH FLEX-TIP, PVC CUFF & STYLET, PARKER, 7.0MM BTR PARKER MEDICAL I-PFTVVCS-70-100 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other