BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASTOTUBE®

    MDR report key: 22736704 · Received August 7, 2025

    Report

    Report Number
    22736704
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    July 31, 2025
    Report Date
    August 1, 2025
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    BSB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHERESIS STAFF OPENED ASTOTUBE INFUSION EXTENSION SET NOTICED THAT END CONNECTION WAS NOT ON TUBING SET. MANUFACTURE STIHLER ELECTRONIC GMBH; LOT# 32464464; EXPIRATION DATE 11/13/2027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940762 ASTOTUBE® WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION BSB STIHLER ELECTRONIC GMBH 32464464

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown