BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVANTA MULTI-PATIENT DISPOSABLE SET

    MDR report key: 5260621 · Received December 2, 2015

    Report

    Report Number
    2520313-2015-00058
    Event Type
    Malfunction
    Date Received
    December 2, 2015
    Date of Event
    November 10, 2015
    Report Date
    November 10, 2015
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K050456
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED MULTI-PATIENT DISPOSABLE SET (MPAT) SYRINGE, LOT NUMBER 8401662. VISUAL EXAMINATION CONFIRMED THE PRESENCE OF A PLASTIC SHEET FRAGMENT IN THE FLUID PATH. THE PARTICLE WAS DETECTED IN THE BARREL OF THE SYRINGE AND MEASURED APPROXIMATELY 6.0 MM IN LENGTH BY 3.0 MM IN WIDTH. THE COMPOSITION OF THE MATERIAL INDICATED THAT THE PARTICULATE COULD POTENTIALLY FRAGMENT WHILE UNDER PRESSURES TYPICALLY GENERATED DURING AN INJECTION. THEREFORE, DUE TO POSSIBLE FRAGMENTATION, THE POTENTIAL OF INJECTION INTO THE PATIENT EXISTS. OUR INVESTIGATION DETERMINED THAT THE PARTICULATE NOTED IN THE SYRINGE WAS INTRODUCED DURING THE MANUFACTURING PROCESS AND WAS NOT DETECTED UPON RECEIPT OF THE SYRINGE FROM THE SUPPLIER. THE SYRINGE KIT INSTRUCTIONS FOR USE INSTRUCTS THE USER TO "VISUALLY INSPECT CONTENTS AND PACKAGE BEFORE EACH USE." THIS VISUAL INSPECTION IS TO ENSURE PARTICULATES ARE NOTICED AND MITIGATED, WHICH IS WHAT OCCURRED IN THIS REPORTED INSTANCE.

    Additional Manufacturer Narrative · 1

    BASED ON THE LIMITED INFORMATION, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE UNKNOWN PARTICULATE AT THIS TIME; HOWEVER, THE PRODUCT IS SCHEDULED TO RETURN TO (B)(6) FOR A FULL EVALUATION. ONCE THE EVALUATION IS COMPLETED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS INFORMATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, THE COMPANY OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THIS REPORTABLE EVENT.

    Description of Event or Problem · 1

    A BAYER REPRESENTATIVE REPORTED THE FOLLOWING: AFTER OPENING AND FILLING THE AVANTA MULTI-PATIENT STERILE DISPOSABLE SET (MPAT), A FOREIGN BODY WAS SEEN IN THE SYRINGE. THE SITE ELECTED NOT TO USE THE SYRINGE. NO INJURY OR ADVERSE EVENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    792719 AVANTA MULTI-PATIENT DISPOSABLE SET ANGIOGRAPHIC TUBING SET DXT BAYER MEDICAL CARE, INC. 3040571 8401662

    Patients

    Seq Age Sex Outcome Treatment
    1