BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGHTSPOT PH ENFIT INDICATOR

    MDR report key: 11562469 · Received March 24, 2021

    Report

    Report Number
    11562469
    Event Type
    Malfunction
    Date Received
    March 24, 2021
    Date of Event
    March 2, 2021
    Report Date
    March 15, 2021
    Manufacturer
    RIGHTBIO METRICS
    Product Code
    JLK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    NG TUBE INSERTED TO 19CM. RIGHTSPOT PH ENFIT INDICATOR ATTACHED TO CHECK PLACEMENT. WHEN ASPIRATING TO CHECK PLACEMENT, AIR CONTINUED TO COME BUT NO FLUID. WHEN PH INDICATOR DETACHED FROM THE END OF THE NG TUBE AND FEEDING SYRINGE ATTACHED, <1ML AIR WAS ABLE TO BE ASPIRATED. ANOTHER RIGHTSPOT PH INDICATOR WAS OBTAINED AND USED WITH THE SAME RESULTS. PH INDICATORS CHECKED FOR CRACKS, BUT NO CRACKS WERE OBVIOUSLY VISIBLE. NG PLACEMENT DOUBLE CHECKED WITH ANOTHER RN BY AUSCULTATION AND ASPIRATION. BUBBLES AUSCULTATED OVER THE STOMACH AND SMALL AMOUNTS OF BREASTMILK/FORMULA ABLE TO BE ASPIRATED FROM THE NG WITH A FEEDING SYRINGE. RIGHTSPOT PH INDICATOR & PACKAGING SAVED IN A BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459632 RIGHTSPOT PH ENFIT INDICATOR SODIUM HYDROXIDE AND PHENOL RED (TITRIMETRIC), GASTRIC ACIDITY JLK RIGHTBIO METRICS EN0920201

    Patients

    Seq Age Sex Outcome Treatment
    1