BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOCSN PATIENT BREATHING PACKAGE

    MDR report key: 20219134 · Received September 14, 2024

    Report

    Report Number
    3013095415-2024-00676
    Event Type
    Malfunction
    Date Received
    September 14, 2024
    Date of Event
    June 5, 2024
    Report Date
    August 28, 2024
    Manufacturer
    VENTEC LIFE SYSTEMS, INC
    Product Code
    CBK
    UDI-DI
    00855573007587
    PMA / PMN Number
    K162877
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H6: THE CONTRACT MANUFACTURER, VINCENT MEDICAL, WAS NOTIFIED OF THE REPORTED ISSUE. THE REPORTED ISSUE OF PATIENT CIRCUIT DELAMINATION WAS CONFIRMED VISUALLY USING THE CUSTOMER PROVIDED PHOTO. THE CONTRACT MANUFACTURER PERFORMED AN INVESTIGATION AND ADVISED VENTEC THAT THE RELEVANT EXTRUSION PROCESS HAD BEEN VALIDATED AND STATE OF VALIDATION HAD BEEN MAINTAINED. ALL ASSOCIATED DHRS FOR THE PART NUMBER AND LOT CODE WERE REVIEWED AND THEY DID NOT IDENTIFY ANY DELAMINATION FAILURES. ADDITIONALLY, THERE WERE NO DEVIATIONS, NCS, OR EXCURSIONS FROM VALIDATED PROCESS. ALL FINISHED GOODS PRODUCED FROM THE COMMON EXTRUSION LOT AND THE SUSPECT LOT RELEVANT TO THE PART NUMBER AND LOT 233106 HAD PASSED ALL QC TESTING PERFORMED DURING THE EXTRUSION PROCESS, SAMPLING ON THE FINISHED TUBING AND FINISHED DEVICE WITH RESPECT TO DELAMINATION FAILURE. NO PRIOR EVENTS OF DELAMINATION DURING MANUFACTURING PROCESS OF VENTEC CIRCUITS WERE IDENTIFIED. THE CAUSE OF THE REPORTED ISSUE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H6: AT THE TIME IF THIS MDR SUBMISSION, SECTION D4 UDI# IS "UNKNOWN" AS IT WAS NOT PROVIDED BY THE INITIAL REPORTER. BECAUSE THE UDI# IS CURRENTLY UNKNOWN, SECTION H4 DEVICE MANUFACTURER DATE SHALL BE LEFT BLANK. UPON RECEIPT OF THE PATIENT CIRCUIT, VENTEC WILL BE ABLE TO OBTAIN THE UDI# AND PROVIDE UPDATES TO SECTION D4 AND SECTION H4. FURTHERMORE, UPON RECEIPT OF THE PATIENT CIRCUIT, VENTEC WILL PERFORM AN EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE AS DEFINED BY 21 CFR 803.56.

    Additional Manufacturer Narrative · 0

    D4: VENTEC WAS SUBSEQUENTLY ABLE TO OBTAIN THE UDI. SECTION D4, UNIQUE IDENTIFIER (UDI) #, HAS BEEN UPDATED FROM UNKNOWN TO (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO VENTEC THAT THE CLEAR FILM WALL OF A BREATHING CIRCUIT HAD DETACHED FROM THE BLUE POLYPROPYLENE SPIRAL PORTION OF THE PATIENT CIRCUIT (PEDIATRIC, ACTIVE, OXYGEN, BLUE) ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152811 VOCSN PATIENT BREATHING PACKAGE VENTILATOR, CONTINUOUS, FACILITY USE CBK VENTEC LIFE SYSTEMS, INC PEDIATRIC, ACTIVE, OXYGEN, BLUE 233106 00855573007587

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown