BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERITUS

    MDR report key: 19350628 · Received May 20, 2024

    Report

    Report Number
    19350628
    Event Type
    Malfunction
    Date Received
    May 20, 2024
    Date of Event
    February 22, 2024
    Report Date
    March 7, 2024
    Manufacturer
    KENTEC MEDICAL, INC.
    Product Code
    FPD
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    SITUATION: ENFIT ENTERAL FEEDING EXTENSION SET ORANGE STRIPED TUBING WAS BEING USED TO ADMINISTER MEDICATION TO A NASO-DUODENUM (ND) TUBE USED BY A PATIENT. THE ND TUBE WAS FOUND TO BE LEAKING WHERE THE ENFIT TUBE CONNECTS TO THE ND TUBE. THE AMOUNT OF MEDICATION THAT THE PATIENT RECEIVED WAS UNKNOWN DUE TO SOME OF IT LEAKING ON THE FLOOR. BACKGROUND: MOTHER OF PATIENT SAID THIS HAPPENED TO PATIENT A FEW DAYS AGO. OTHER NURSE ON THE UNIT SAID THEY HAVE HAD ISSUES WITH THE ENFIT TUBES IN RECENT WEEKS. ASSESSMENT: UPON LOOKING AT THE CONNECTION CLOSER, RN REALIZED THAT THE FEMALE END OF THE ENFIT LUER LOCK WOULD NOT TIGHTEN ON TO THE THE ND FEMALE LUER LOCK. IT JUST KEPT SPINNING AND SPINNING. AS A RESULT OF IT NOT BEING ABLE TO BE TIGHTENED, IT WAS LEAKING. RN WENT AND GOT ANOTHER OF THE SAME PRODUCT AND IT DID TIGHTEN. EVERY OTHER ORAL SYRINGE RN GOT SMALLER THAN 60 CC ALSO TIGHTENED. RECOMMENDATION: DO NOT HAVE A SPECIFIC LOT NUMBER FOR THE BROKEN ONE BECAUSE IT WAS ALREADY IN PLACE, BUT THE LOT NUMBER OF THE ONES CURRENTLY STOCKED ON THE UNIT IS KS2308007. AMERITUS PRODUCT BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860784 AMERITUS TUBE, FEEDING FPD KENTEC MEDICAL, INC. KS2308007

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Unknown