BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N/A

    MDR report key: 19397867 · Received May 24, 2024

    Report

    Report Number
    3000219639-2024-00044
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 25, 2024
    Report Date
    July 23, 2024
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    UDI-DI
    00607411915833
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 24 MAY 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 24 MAY 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 "PIN HOLES IN CANNULA TUBING." THE COMPLAINT INVESTIGATION WAS PERFORMED BASED ON THE CONTENT OF THE ISSUE REPORTED. BASED ON THE COMPLAINT REPORT THE ISSUE WAS FOUND DURING SET-UP. THEREFORE, NO PATIENT WAS IMPACTED OR HARMED. PHOTO IMAGES WERE PROVIDED FOR EVALUATION AND CONFIRMED. NCM-03911 WAS OPENED DUE TO BREAK WAS FOUND DURING REQUESTING AN INVENTORY EVALUATION AND CONFIRMED DURING THE VISUAL INSPECTION BY THE MANUFACTURE SITE. 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 SECOND (2) COMPLAINT REPORTED FOR PART NUMBER 16SOFT-4-50 FOR "PINHOLE." THERE WERE NINE (9) COMPLAINTS REPORTED FOR PART NUMBER 16SOFT-4-50 DURING THE SAME TIMEFRAME FOR OTHER FAILURE MODES. WE WILL CONTINUE TO MONITOR TRENDS DURING OUR PERIODIC COMPLAINT REVIEW MEETINGS.

    Description of Event or Problem · 0

    PIN HOLES IN CANNULA TUBING.

    Description of Event or Problem · 0

    PIN HOLES IN CANNULA TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643869 N/A SALTER STYLE NASAL O2 CANNULA (ADULT), 4' (1.2 M) 0 TO 6 LPM, NON DEHP CAT SALTER LABS 16SOFT-4 UNKNOWN 00607411915833

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other