BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARKER

    MDR report key: 23251538 · Received October 8, 2025

    Report

    Report Number
    3004748541-2025-00077
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    August 8, 2025
    Report Date
    March 4, 2026
    Manufacturer
    PARKER MEDICAL
    Product Code
    BTR
    UDI-DI
    00607411954436
    PMA / PMN Number
    K100546
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 08 OCT 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.

    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 08 OCT 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 (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, 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. DEVICE HISTORY RECORD (DHR) REVIEW: NO ISSUES FOUND IN THE DHR. BASED ON THE DEVICE HISTORY RECORD (DHR) REVIEW THERE WERE NO ABNORMAL PROCESSING ISSUES NOTED. ALL PRODUCTS/PACKAGING WERE PRODUCED PER THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND INSPECTIONS. RISK ASSESSMENT: THE ULTIMATE RISK IS LOW, AS THAT IS THE HIGHEST RISK OF THE PATIENT/CAREGIVER AND REGULATORY/COMPLIANCE CONSIDERATIONS: 1. PATIENT/ CAREGIVER PERFORMED RISK ASSESSMENT WITH (B)(4) REV 3. THE COMPLAINT MOST CLOSELY ALIGNS WITH RISK ID R25 WITH A POTENTIAL CAUSE OF HAZARD BEING "CUFF HAVING PIN HOLE". SEVERITY = 6, LIKELIHOOD OF OCCURRENCE = 2, CALCULATED OCCURRENCE = 0.023%. PER REF-20001-C1 REV 2, THESE LEVELS INDICATE LOW RISK. 2. REGULATORY/ COMPLIANCE REVIEWED REF-20001-C1 REV 2, AND THERE IS LOW REGULATORY/ COMPLIANCE RISK. 3. BRAND RECOGNITION AND CUSTOMER IMPACT REVIEWED REF-20001-C1 REV 2, AND THERE IS LOW BRAND RECOGNITION/CUSTOMER IMPACT. COMPLAINT HISTORY REVIEW: THE COMPLAINT HISTORY WAS REVIEWED IN GRAND AVENUE FROM REPORTED DATES 09/08/23 THROUGH 09/08/25, FOR PART NUMBER I-PFNC-70 AND FAILURE MODE "A050402 - GAS/AIR LEAK". THERE WERE 3 OTHER COMPLAINTS REPORTED FOR THE SAME ISSUE AND PART NUMBER UNDER (B)(4) DURING THE SAME TIMEFRAME. SALES = (B)(4) EA. CALCULATED OCCURRENCE (P1) = (B)(4) X 100 = (B)(4). OCCURRENCE RANKING = 4.

    Description of Event or Problem · 0

    IT WAS REPORTED: AFTER INTUBATION, THE MEDICAL STAFF TRIED TO INFLATE THE CUFF, BUT THEY COULD NOT, THE TUBE WAS CHANGED. AFTER THE TUBE CHANGED THEY ATTEMPTED TO INFLATE THE CUFF AND IT WOULD NOT INFLATE. THERE WAS NO REPORTED INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED: AFTER INTUBATION, THE MEDICAL STAFF TRIED TO INFLATE THE CUFF, BUT THEY COULD NOT, THE TUBE WAS CHANGED. AFTER THE TUBE CHANGED THEY ATTEMPTED TO INFLATE THE CUFF AND IT WOULD NOT INFLATE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139011 PARKER ENDOTRACHEAL TUBE, PREFORMED NASAL, HIGH VOLUME LOW PRESSURE, CUFFED (PFNC), PA BTR PARKER MEDICAL H-PFNC-70 2501NC0096K 00607411954436

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other