BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BT-BALLOON TAMPONADE CATHETER FOR POSTPARTUM UTERINE HEMORRHAGE WITH EASY FILL I

    MDR report key: 9592607 · Received January 14, 2020

    Report

    Report Number
    MW5092249
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    January 7, 2020
    Report Date
    January 10, 2020
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    OQY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO A UTAH BALLOON WHICH WAS USED ON A PT. BT - BALLOON TAMPONADE CATHETER FOR POSTPARTUM UTERINE HEMORRHAGE WITH EASY FILL INFLATION SYSTEMS UTAH MEDICAL PRODUCTS (B)(4), BTC-ESY, LOT# 1191599, EXP 2024-09-17. DURING TRAINING, I OPENED THE PACKAGE AND TRIED TO CONNECT THE CLEAR LUER LOCK PORT TO THE BLUE STOP COCK AND NO MATTER WHAT I DID IT WOULD NOT SCREW ON. FIRST WHEN I OPENED IT ON THE CLEAR LUER LOCK PART, THE CIRCULAR TUBE IN IT WAS BENT TO THE SIDE SO I HAD TO BEND IT BACK AND IT STILL WOULDN'T WORK. THE LOT NUMBER 1191599 ON THIS DEVICE IS THE SAME LOT NUMBER, REPORTED IN RM# 19-61223. THE LUER LOCK IS VISIBLY DEFECTIVE, HOWEVER, IT IS DIFFICULT TO PHOTOGRAPH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52144 BT-BALLOON TAMPONADE CATHETER FOR POSTPARTUM UTERINE HEMORRHAGE WITH EASY FILL I INTRAUTERINE TAMPONADE BALLOON OQY UTAH MEDICAL PRODUCTS, INC. BTC-ESY 1191599

    Patients

    Seq Age Sex Outcome Treatment
    1