BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER

    MDR report key: 19659175 · Received July 2, 2024

    Report

    Report Number
    3000219639-2024-00052
    Event Type
    Malfunction
    Date Received
    July 2, 2024
    Date of Event
    May 21, 2024
    Report Date
    July 29, 2024
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    PMA / PMN Number
    K984528
    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 02 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 09740. 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 "INFLATING TUBE FELL OUT OF THE BODY OF THE ITEM 23 DAYS AFTER THE TRACHEAL TUBE WAS INTUBATED. THE PATIENT WAS ALSO USING A BITE BLOCK IN CONJUNCTION WITH THE TUBE." BASED ON THE SUPPLIER EVALUATION THE RETAINED SAMPLE DID NOT HAVE ANY CONFORMITY FINDINGS. WELL LEAD INVESTIGATION CONCLUDED ON JUNE 03, 2024. WELL LEAD RECEIVED A COMPLAINT, THE CUSTOMER DECLARED THAT THE INFLATION TUBE WAS DETACHED FROM THE MAIN TUBE AFTER INTUBATION 23 DAYS. THE RECOMMENDED TIME FOR PARKER TUBE INTUBATION IS NO MORE THAN 30 DAYS. THE STIFFNESS OF TUBE WILL NOT CHANGE OBVIOUSLY, AND IT WILL NOT SLIP JOINTS TO COME OUT SOMETIMES. THE ROOT PART OF THE INFLATION TUBE HAS CYCLOHEXANONE FOR BONDING, AND IT ALSO HAS UV GLUE FOR REINFORCING. THE HARDNESS OF TUBE IS NOT HARDER THAN OTHER COMPANIES, AND THE HARDNESS OF TUBING WILL NOT CAUSE OF THE INFLATION TUBE FALLING OFF. THE PLACE OF INFLATION TUBE IS SOFT, AND THE BITE BLOCK OR ANCHOR WILL SQUEEZE THIS PLACE IF THE PATIENT BITES THE BLOCK OR ANCHOR. WELL LEAD SUGGESTS THE PHYSICIAN NOT FIX THE BITE BLOCK AND ANCHOR ON THE PLACE OF INFLATION TUBE UNLESS NECESSARY, AND WELL LEAD ALSO FOUND PHYSICIAN MAY HAVE USED SOME GLUE TO ADHERE THE BLOCK OR ANCHOR, BUT IT MAY HAVE CAUSED THE TUBE TO BE PULLED WITH THE BLOCK AND LEAD TO INFLATION TUBE FALL OFF. A RISK ASSESSMENT DETERMINED THE ULTIMATE RISK TO BE LOW, WHICH DOES NOT REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THIS IS THE FIRST COMPLAINT REPORTED FOR PART NUMBER I-PFHV-75-10. THERE WERE NO OTHER REPORTED COMPLAINTS REPORTED FOR PART NUMBER I-PFHV-75-10 DURING THE SAME TIMEFRAME. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 02 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.

    Description of Event or Problem · 0

    INFLATING TUBE FELL OUT OF THE BODY OF THE ITEM 23 DAYS AFTER THE TRACHEAL TUBE WAS INTUBATED. THE PATIENT WAS ALSO USING A BITE BLOCK IN CONJUNCTION WITH THE TUBE.

    Description of Event or Problem · 0

    INFLATING TUBE FELL OUT OF THE BODY OF THE ITEM 23 DAYS AFTER THE TRACHEAL TUBE WAS INTUBATED. THE PATIENT WAS ALSO USING A BITE BLOCK IN CONJUNCTION WITH THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603045 PARKER ENDOTRACHEAL TUBE, HIGH VOLUME LOW PRESSURE (PFHV), CUFFED, PARKER, 7.5MM ORIGIN BTR PARKER MEDICAL H-PFHV-75 2101NV0018K

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other