BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT CT SYRINGE KIT

    MDR report key: 7037933 · Received November 16, 2017

    Report

    Report Number
    2520313-2017-00071
    Event Type
    Malfunction
    Date Received
    November 16, 2017
    Date of Event
    October 21, 2017
    Report Date
    November 16, 2017
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER QUALITY ASSURANCE PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED LOW PRESSURE CONNECTING TUBING (LPCT), LOT #8522105. THE DEFECT WAS IDENTIFIED AS DEGRADED COMPOUND (RESIN) THAT IS PARTIALLY EMBEDDED IN THE TUBING WALL AND EXTENDS INTO THE FLUID PATHWAY. THE CAUSE OF THE REPORTED PROBLEM IS DEGRADED COMPOUND (RESIN) THAT COLLECTED ON THE EXTRUSION TOOLING AND BECAME PARTIALLY EMBEDDED IN THE TUBING AS IT WAS FORMED DURING MANUFACTURING. A 12 MONTH REVIEW OF COMPLAINT HISTORY DETERMINED THE FREQUENCY TO BE (B)(4) COMPLAINTS PER MILLION (CPM) FOR SIMILAR DEFECTS.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A STELLANT DISPOSABLE SET HAS VISIBLE FOREIGN MATERIAL IN THE TUBING. THIS IS A SJS-PT-J SYRINGE KIT. THE KIT WAS REMOVED FROM THE AREA AND WAS NOT USED FOR A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815815 STELLANT CT SYRINGE KIT ANGIOGRAPHIC SYRINGE KIT DXT BAYER MEDICAL CARE, INC. 60729334 8522105

    Patients

    Seq Age Sex Outcome Treatment
    1