BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STOPCOCK

    MDR report key: 9511154 · Received December 23, 2019

    Report

    Report Number
    1416980-2019-07094
    Event Type
    Malfunction
    Date Received
    December 23, 2019
    Report Date
    January 22, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FMG
    PMA / PMN Number
    K130245
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: STOPCOCK, I.V. SET (PREVIOUSLY SET, ADMINISTRATION, INTRAVASCULAR) CORRECTION MADE TO CLASSIFICATION CODE: FMG (PREVIOUSLY FPA). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED "CONTINUAL CONCERNS WITH HEMOLYSIS" WITH AN UNSPECIFIED QUANTITY OF LARGE BORE STOPCOCKS WITH ROTATING MALE LUER LOCK. THIS WAS IDENTIFIED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO REPORT OF 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
    1304733 STOPCOCK STOPCOCK, I.V. SET FMG BAXTER HEALTHCARE CORPORATION NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1