BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIATION STERILIZED EXTENSION SETS

    MDR report key: 8621710 · Received May 17, 2019

    Report

    Report Number
    1416980-2019-02754
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Report Date
    June 12, 2019
    Manufacturer
    BAXTER HEALTHCARE - TUNISIA
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION : 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 AN EXTENSION SET WAS DIFFICULT TO FLUSH. THE REPORTER STATED THAT THIS OCCURRED WHEN THE NURSE CONNECTED THE LINE. THE CONNECTION WAS FULLY TIGHTENED AND THERE DID NOT APPEAR TO BE ANY CROSS-THREADING. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415193 RADIATION STERILIZED EXTENSION SETS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - TUNISIA NA 18J21T191N

    Patients

    Seq Age Sex Outcome Treatment
    1