BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER

    MDR report key: 20103279 · Received August 29, 2024

    Report

    Report Number
    3000219639-2024-00066
    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 10253. 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. ON JULY 31, 2024, WELL LEAD RECEIVED THE CUSTOMER COMPLAINT FROM M C MEDICAL THAT THE USER DECLARES THAT THE CUFF WAS LEAKED AND DAMAGED AFTER INTUBATION, BUT PRODUCT HAS BEEN PASSING THE PRIOR TEST BEFORE INTUBATION. WELL LEAD REVIEWED 3PCS RETAINED SAMPLES OF LOT NUMBER 2111ST2254L, NO DAMAGE OR LEAKAGE WAS FOUND IN RETAINED SAMPLES, THEY ALL QUALIFIED. WELL LEAD REVIEWED THE DHR OF LOT NUMBER 2111ST2254L, NO ABNORMITY WAS FOUND IN DHR. THE RESULTS ARE AS FOLLOWS, 1. MAN, THE WORKERS HAVE BEEN TRAINED ON THE OPERATION. 2. MACHINE FOR THE PRODUCTION PROCESS, WE HAVE CONDUCTED THE VALIDATION, AND THE MACHINES ARE QUALIFIED FOR MANUFACTURE. 3.MATERIAL NO CHANGE IN THE MATERIAL OF THE CUFF. THE MATERIAL HAS BEEN VALIDATED BY THE USE AND TESTING. 4. METHOD THE STAFF WORK IN ACCORDANCE WITH SOP. 5. ENVIRONMENT THE ENVIRONMENT OF THE WORKSHOP IS IN THE CONTROL OF MONITOR. WELL LEAD ASKED SOME QUESTIONS TO DISTRIBUTOR (M C MEDICAL) FOR FURTHER INVESTIGATION, THE RESPONSE AS FOLLOWS, 1. HOW LONG THE PRODUCT BE USED ON PATIENT? - IMMEDIATELY AFTER INTUBATION. I THINK IT IS ABOUT 1 MINUTE AFTER INTUBATION. 2. DID THE PHYSICIAN USE ANY DEVICE FOR INTUBATION? - SHE OR HE WAS NOT USING IT 3. DID THE PATIENT HAVE ANY SHARP THING IN MOUTH MAY CAUSE THE CUFF LEAKAGE? - SHE OR HE WAS NOT USING IT. WE HAVE 100% INSPECTION OF THE LEAKAGE IN WORKSHOP AND THE CUFF HAS 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 (1) COMPLAINT REPORTED FOR PART NUMBER I-PFST-75-10. THERE WERE NO OTHER REPORTED COMPLAINTS REPORTED FOR PART NUMBER I-PFST-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 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

    DURING INTUBATION, A LEAK WAS FOUND. SCRATCHES FOUND ON THE CUFF.

    Description of Event or Problem · 0

    DURING INTUBATION, A LEAK WAS FOUND. SCRATCHES FOUND ON THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1355166 PARKER PARKER FLEX-TIP TRACHEAL TUBE WITH STYLET, HIGH VOLUME LOW PRESSURE, CUFFED BTR PARKER MEDICAL H-PFST-75 2111ST2254L 00607411959288

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other