BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTRAN PLUS NEEDLELESS ARTERIAL BLOOD COLLECTION SYSTEM

    MDR report key: 5009875 · Received August 18, 2015

    Report

    Report Number
    5009875
    Event Type
    Malfunction
    Date Received
    August 18, 2015
    Date of Event
    May 11, 2015
    Report Date
    August 7, 2015
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC.
    Product Code
    DRS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NURSING STAFF IDENTIFIED THREE NEWLY OPENED DELTRAN ARTERIAL TRANSDUCERS WHICH WERE BROKEN. NONE OF THE THREE IDENTIFIED HAD BEEN USED ON A PATIENT. THESE THREE BROKEN DEVICES WERE RETURNED TO THE MANUFACTURER. MANUFACTURER RESPONSE FOR PEDIATRIC ARTERIAL BLOOD COLLECTION KIT, DELTRAN PLUS NEONATAL/PEDIATRIC ARTERIAL BLOOD COLLECTION KIT (PER SITE REPORTER). INITIALLY, MANUFACTURER'S REP RESPONSE WAS TO REPLACE ONLY THE 3 BROKEN DEVICES, NOT THE ENTIRE LOT. THIS WAS RESOLVED WITH THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546229 DELTRAN PLUS NEEDLELESS ARTERIAL BLOOD COLLECTION SYSTEM TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS UTAH MEDICAL PRODUCTS, INC. 1142491

    Patients

    Seq Age Sex Outcome Treatment
    1 NO OTHER THERAPIES