BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COSEAL

    MDR report key: 6114154 · Received November 18, 2016

    Report

    Report Number
    1416980-2016-17477
    Event Type
    Malfunction
    Date Received
    November 18, 2016
    Date of Event
    October 23, 2016
    Report Date
    November 18, 2016
    Manufacturer
    BAXTER HEALTHCARE - HAYWARD
    Product Code
    NBE
    PMA / PMN Number
    P030039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE VISIBLE PARTICLES IN THE PEG SYRINGE OF A COSEAL SURGICAL SEALANT KIT. THIS OCCURRED AFTER RECONSTITUTION, BUT BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763529 COSEAL SEALANT,POLYMERIZING NBE BAXTER HEALTHCARE - HAYWARD NA HA151037

    Patients

    Seq Age Sex Outcome Treatment
    1