BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDLINE EXTENSION TUBING

    MDR report key: 18435361 · Received January 2, 2024

    Report

    Report Number
    MW5149723
    Event Type
    Other
    Date Received
    January 2, 2024
    Report Date
    December 20, 2023
    Manufacturer
    MEDLINE INDUSTRIES, LP - NORTHFIELD
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I WAS CONTACTED BY THE STAFF TODAY TO RELAY A MESSAGE THEY'VE HAD SEVERAL BSC WATCHDOG HEMOSTATIC VALVES THAT WERE UNABLE TO ATTACH TO EXTENSION TUBING. THEY REPLACED IT WITH ANOTHER ONLY TO DISCOVER THAT THE NEXT EXTENSION TUBING WAS ALSO DEFECTIVE. THE REPORTER STATED THAT THE THREADS LOOKED MALFORMED. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2). REFERENCE REPORT: MW5149722.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699613 MEDLINE EXTENSION TUBING SET, ADMINISTRATION, INTRAVASCULAR FPA MEDLINE INDUSTRIES, LP - NORTHFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown