BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARKER

    MDR report key: 20328133 · Received September 27, 2024

    Report

    Report Number
    3000219639-2024-00073
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 27, 2024
    Report Date
    October 8, 2024
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    10749065191700
    PMA / PMN Number
    N/A
    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 27 SEPT 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 27 SEPT 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 COMPLAINT WAS CONSIDERED CONFIRMED BASED ON CUSTOMER NARRATIVE OF EVENTS. A 24 MONTH REVIEW WAS CONDUCTED AND NO ADDITIONAL COMPLAINTS WERE IDENTIFIED RELATED TO THIS ISSUE AND NO TREND WAS OBSERVED. THE LOT NUMBER WAS 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

    THE TUBE WAS INTUBATED INTO THE PATIENT ON (B)(6). ON (B)(6), THE VENTILATOR WAS REMOVED, AND AN ATTEMPT WAS MADE TO EXTUBATE THE PATIENT, BUT THE TUBE COULD NOT BE REMOVED. AT THAT TIME, THE TUBE COULD NOT BE PUSHED IN. SUSPECTING EDEMA, A STEROID WAS ADMINISTERED, AND AFTER A DAY OF OBSERVATION, ANOTHER ATTEMPT WAS MADE ON (B)(6), BUT THE PATIENT COULD NOT BE EXTUBATED. ON (B)(6), THE SURGEON WAS ABLE TO PUSH THE TUBE IN.THE ANESTHESIOLOGY DEPARTMENT CONSULTED WITH THE SURGEON AND OTOLARYNGOLOGY DEPARTMENT, AND ON (B)(6), A TRACHEOTOMY WAS PERFORMED IN THE OP ROOM, AND ONLY THE TIP OF THE TUBE WAS REMOVED FROM THE TRACHEOSTOMY SITE. IN ORDER TO REMOVE THE TUBE TIP, A LARGER INCISION WAS MADE THAN A NORMAL TRACHEOTOMY. WHEN THE TUBE WAS REMOVED, THE PATIENT WAS VENTILATED WITH THE INTUBATED TUBE UP TO THE TRACHEOSTOMY. FROM THE TRACHEOSTOMY, THE END OF THE TUBE WAS FIRST CUT OFF, AND ONLY THE END OF THE TUBE, INCLUDING THE CUFF, WAS REMOVED FROM THE TRACHEOSTOMY SITE. THE TUBE COULD NOT BE PUSHED IN.,

    Description of Event or Problem · 0

    THE TUBE WAS INTUBATED INTO THE PATIENT ON AUGUST 13. ON AUGUST 19, THE VENTILATOR WAS REMOVED, AND AN ATTEMPT WAS MADE TO EXTUBATE THE PATIENT, BUT THE TUBE COULD NOT BE REMOVED. AT THAT TIME, THE TUBE COULD NOT BE PUSHED IN.[?]SUSPECTING EDEMA, A STEROID WAS ADMINISTERED, AND AFTER A DAY OF OBSERVATION, ANOTHER ATTEMPT WAS MADE ON AUGUST 20, BUT THE PATIENT COULD NOT BE EXTUBATED. ON AUGUST 21, THE SURGEON WAS ABLE TO PUSH THE TUBE IN.THE ANESTHESIOLOGY DEPARTMENT CONSULTED WITH THE SURGEON AND OTOLARYNGOLOGY DEPARTMENT, AND ON AUGUST 22, A TRACHEOTOMY WAS PERFORMED IN THE OP ROOM, AND ONLY THE TIP OF THE TUBE WAS REMOVED FROM THE TRACHEOSTOMY SITE. IN ORDER TO REMOVE THE TUBE TIP, A LARGER INCISION WAS MADE THAN A NORMAL TRACHEOTOMY. WHEN THE TUBE WAS REMOVED, THE PATIENT WAS VENTILATED WITH THE INTUBATED TUBE UP TO THE TRACHEOSTOMY. FROM THE TRACHEOSTOMY, THE END OF THE TUBE WAS FIRST CUT OFF, AND ONLY THE END OF THE TUBE, INCLUDING THE CUFF, WAS REMOVED FROM THE TRACHEOSTOMY SITE. THE TUBE COULD NOT BE PUSHED IN.,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1610451 PARKER PARKER TRACH VAC WITH FLEX-TIP AND PVC CUFF (H-PFTVVC), 7.0MM BTR PARKER MEDICAL H-PFTCCV-70 2401STV0248K 10749065191700

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other