BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 14701685 · Received June 15, 2022

    Report

    Report Number
    3000219639-2022-00027
    Event Type
    Malfunction
    Date Received
    June 15, 2022
    Date of Event
    May 16, 2022
    Report Date
    June 15, 2022
    Manufacturer
    SALTER LABS
    Product Code
    BYX
    UDI-DI
    10607411200639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS PATIENT WAS HOSPITALIZED AFTER TRIPPING OVER TUBING.

    Additional Manufacturer Narrative · 0

    REPORTABLE AS PATIENT WAS HOSPITALIZED AFTER TRIPPING OVER TUBING. A REVIEW OF COMPLAINTS SUBMITTED OVER THE PAST 24 MONTHS FOR THE PRODUCT FAMILY "12-TUBING/CONNECTOR" AND FOUND FOUR PREVIOUS COMPLAINTS. THIS IS ISSUE IS NOT TRENDING FOR THIS PRODUCT OR FAMILY OF PRODUCT AS THERE IS AN OVERALL DOWNWARD TREND. AN INVENTORY SEARCH WAS CONDUCTED FOR THIS PART NUMBER AND LOT # AND STOCK WAS NO LONGER AVAILABLE IN INVENTORY. DHRS WERE REVIEWED FOR THE TUBING EXTRUSION OPERATION AS WELL AS THE FINISHED PACKAGING PROCESS. NO NONCONFORMANCES WERE NOTED AND IN PROCESS CHECKS WERE PERFORMED AND PASSED ALL SUCCESS CRITERIA. THE TUBING IS EXTRUDED AND AUTOMATICALLY FED INTO AN AUTO-COILING CONTAINER. THE PROCESS IS CONTROLLED WHICH MINIMIZES DAMAGE TO TUBING MATERIAL AND LOWERS THE RISK OF ATYPICAL BEHAVIOR OF THE TUBING MATERIAL. THE MOST LIKELY CAUSE FOR THE COILING IS IMPROPER USAGE OR STORAGE OF THE CANNULA LEADING TO MATERIAL COILING. (B)(4) REV 3: R77 IDENTIFIES TRIPPPING FROM TUBING CAUSING A FALL AS A SEVERE (8/10) SEVERITY. THIS COMPLAINT WAS REVIEWED AT 5/26/2022 CARB AND WAS APPROVED FOR NO CAPA.

    Description of Event or Problem · 0

    THE TUBING COILS AND CAUSED A PATIENT TO FALL. THE END USER STATED HE HAS CHANGED HIS TUBING MULTIPLE TIMES AND CONTINUES TO HAVE ISSUES WITH IT COILING. HE ORDERS THROUGH APRIA AND VITALITY MEDICAL. THE PATIENT FELL AND ENDED UP IN THE HOSPITAL BECAUSE HE TRIPPED OVER THE TUBING.

    Description of Event or Problem · 0

    THE TUBING COILS AND CAUSED A PATIENT TO FALL. THE END USER STATED HE HAS CHANGED HIS TUBING MULTIPLE TIMES AND CONTINUES TO HAVE ISSUES WITH IT COILING. HE ORDERS THROUGH APRIA AND VITALITY MEDICAL. THE PATIENT FELL AND ENDED UP IN THE HOSPITAL BECAUSE HE TRIPPED OVER THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909551 SALTER LABS TUBING, OXYGEN, 3-CHANNEL 50' (GREEN) - 20/CS BYX SALTER LABS 2050G-50-20 21022B 10607411200639

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other