BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOSE RETRACTOR

    MDR report key: 13239953 · Received January 12, 2022

    Report

    Report Number
    1419185-2022-00001
    Event Type
    Malfunction
    Date Received
    January 12, 2022
    Report Date
    January 12, 2022
    Manufacturer
    OHIO MEDICAL LLC
    Product Code
    BYX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    OHIO MEDICAL LLC WAS CONTACTED ON DECEMBER 10, 2021 REGARDING A HOSE RETRACTOR ZIP TIE BREAKING AND A PIECE OF PLASTIC FALLING ON A PATIENT. AN INVESTIGATION WAS INITIATED. ON JANUARY 6, 2022 THE OHIO MEDICAL QUALITY ENGINEER SPOKE WITH THE REPRESENTATIVE OF (B)(6). THE HS-RET-HD HOSE RETRACTOR IS AN ACCESSORY TO THE OHIO MEDICAL HOSE ASSEMBLY. IT IS USED TO SUSPEND EXCESS MEDICAL GAS HOSE OVERHEAD WHEN NOT IN USE, TO AVOID INTERFERENCE WITH ACTIVITIES IN THE SPACE BELOW. THE RETRACTOR IS MOUNTED TO THE OVERHEAD MEDICAL GAS OUTLET ALONGSIDE THE HOSE CONNECTION. THE HOSE IS SECURED TO THE END OF THE SPRING LOADED RETRACTOR CABLE BY A SHORT LENGTH OF TUBING AND CABLE TIE. THE RESULT OF THE INTERVIEW DETERMINED THAT THE PLASTIC ZIP TIE BROKE AND A SMALL PIECE OF PLASTIC FELL ONTO THE PATIENT. THE HOSE AND HOSE RETRACTOR REMAINED ATTACHED TO THE CEILING AS REQUIRED. NO INJURY OR OTHER ADVERSE CONSEQUENCE OCCURRED AS A RESULT OF THE BROKEN ZIP TIE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226302 HOSE RETRACTOR HOSE RETRACTOR BYX OHIO MEDICAL LLC HS-RET-HD NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown