BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRLIFE, TRI-FLO SUCTION CATH-N-GLOVE KIT

    MDR report key: 21329455 · Received February 6, 2025

    Report

    Report Number
    8030673-2025-00008
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Report Date
    March 5, 2025
    Manufacturer
    VYARRIE MEDICAL
    Product Code
    OFO
    UDI-DI
    10190752148956
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE RETURNED PRODUCT DETERMINED THE PRODUCT WAS UNACCEPTABLE DUE TO BLACK MATERIAL SEEN ON THE PRODUCT. THE REPORTED EVENT COULD BE CONFIRMED AS REPORTED, THE ROOT CAUSE WAS DETERMINED TO BE MATERIAL RELATED. THE DEVICE HISTORY RECORD FOR LOT 0004247691 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 05 MAR 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE ACTUAL SAMPLE FROM THE REPORTED EVENT WAS RETURNED AND PROCESSED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 0004247691 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 06 FEB 2025 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 SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS LLC. SUN MED HOLDINGS LLC. 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 SUN MED HOLDINGS COMPLAINT DATABASE AND IDENTIFIED AS (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 SUN MED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030673-2025-00007 FOR THE FIRST REPORT IT WAS REPORTED, THE SUCTION CATHETER WAS CONTAMINATED WITH A [UNKNOWN] BLACK MATERIAL. UPON DISCOVERY, A NEW CLOSED SUCTION SYSTEM WAS PLACED. [THE DISCOVERY MAY HAVE LEAD TO] A DELAY IN SUCTIONING. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS POSITIVE FOR SERRATIA (WATER BACTERIA) IN THEIR ENDOTRACHEAL TUBE. AT THE TIME OF THE REPORT, THE PATIENT WAS VENTED, AND IN ISOLATION FOR POSITIVE CULTURES FOR SERRATIA.

    Description of Event or Problem · 0

    SUNMED HOLDINGS LLC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE SECOND OF TWO REPORTS. REFER TO 8030673-2025-00007 FOR THE FIRST REPORT. IT WAS REPORTED; THE SUCTION CATHETER WAS CONTAMINATED WITH A [UNKNOWN] BLACK MATERIAL. UPON DISCOVERY, A NEW CLOSED SUCTION SYSTEM WAS PLACED. [THE DISCOVERY MAY HAVE LEAD TO] A DELAY IN SUCTIONING. IT WAS ADDITIONALLY REPORTED, THE PATIENT WAS POSITIVE FOR SERRATIA (WATER BACTERIA) IN THEIR ENDOTRACHEAL TUBE. AT THE TIME OF THE REPORT, THE PATIENT WAS VENTED, AND IN ISOLATION FOR POSITIVE CULTURES FOR SERRATIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531356 AIRLIFE, TRI-FLO SUCTION CATH-N-GLOVE KIT TRI-FLO SUCTION CATH-N-GLOVE KIT OFO VYARRIE MEDICAL 4893T 0004247691 10190752148956

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown