BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER

    MDR report key: 20103089 · Received August 29, 2024

    Report

    Report Number
    3000219639-2024-00067
    Event Type
    Malfunction
    Date Received
    August 29, 2024
    Date of Event
    July 26, 2024
    Report Date
    August 29, 2024
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    00607411959288
    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 29 AUG 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. THE COMPLAINT REPORTED "AFTER INTUBATION, A LEAK WAS FOUND AFTER 2 DAYS AND THERE WAS A WOUND FOUND ON THE CUFF." THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. BASED ON THE COMPLAINT REPORT NO PATIENT WAS AFFECTED. THE PHYSICAL PRODUCT WAS NOT RETURNED, HOWEVER THE VENDOR PROVIDED PHOTOGRAPHIC EVIDENCE OF THE INCIDENT. ON JULY 31, 2024, WE RECEIVED THE CUSTOMER COMPLAINT FROM M C MEDICAL THAT THE USER DECLARES THAT THE CUFF WAS FOUND LEAKAGE AND DAMAGED IN 2 DAYS AFTER INTUBATION, BUT PRODUCT HAS BEEN PASSING THE PRIOR TEST BEFORE INTUBATION. THE LOT NUMBER IS NOT AVAILABLE, WELL LEAD COULD NOT REVIEW THE RETAINED SAMPLES AND DHR ACCORDINGLY. WELL LEAD ASKED SOME QUESTIONS TO DISTRIBUTOR (M C MEDICAL) FOR FURTHER INVESTIGATION, THE RESPONSE AS FOLLOWS, 1. DID THE PHYSICIAN USE ANY DEVICE FOR INTUBATION? - GUIDEWIRE WAS USED.2. DID THE PATIENT HAVE ANY SHARP THING IN MOUTH MAY CAUSE THE CUFF LEAKAGE? - NO SHARP OBJECTS ARE PUT IN THE MOUTH 3. IS THERE ANY POSTURAL CHANGE IN THE PATIENT? - POSITION CHANGES WERE PERFORMED EVERY 2-3 HOURS. 4.WHAT DISEASE DOES THE PATIENT HAVE? ARE THERE ANY SYMPTOMS OF ASTHMA OR RAPID PRESSURE ON THE AIRWAY? - MAIN ILLNESS: CEREBRAL INFARCTION COVID-19 ONSET DURING HOSPITALIZATION SEPSIS; ACUTE RESPIRATORY DISTRESS SYNDROME; ACUTE RENAL FAILURE WELL LEAD HAVE 100% INSPECTION OF THE LEAKAGE IN WORKSHOP AND THE CUFF HAS BEEN PASSED THE PRIOR TEST BEFORE INTUBATION, SO WE COULD NOT DETERMINE THE ROOT CAUSE FOR THIS CASE IS CAUSED BY PRODUCT ITSELF BASED ON AVAILABLE INFORMATION AND ABOVE INVESTIGATION. 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 FIRST COMPLAINT REPORTED FOR PART NUMBER I-PFHV-75-10 FOR "LEAKING." THERE WERE TWO OTHER REPORTED COMPLAINTS REPORTED FOR PART NUMBER I-PFHV-75-10 DURING THE SAME TIMEFRAME FOR OTHER FAILURE MODES. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 29 AUG 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

    AFTER INTUBATION, A LEAK WAS FOUND AFTER 2 DAYS AND THERE WAS A WOUND FOUND ON THE CUFF.

    Description of Event or Problem · 0

    AFTER INTUBATION, A LEAK WAS FOUND AFTER 2 DAYS AND THERE WAS A WOUND FOUND ON THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522687 PARKER PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED BTR PARKER MEDICAL H-PFST-75 UNKOWN 00607411959288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other