BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS 3-WAY STOPCOCK

    MDR report key: 3550015 · Received November 6, 2013

    Report

    Report Number
    9616066-2013-00860
    Event Type
    Malfunction
    Date Received
    November 6, 2013
    Report Date
    October 14, 2013
    Manufacturer
    ELCAM MEDICAL ACAL
    Product Code
    FMG
    PMA / PMN Number
    022895
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT WILL BE RETURNED BY CUSTOMER. THE CUSTOMER COMPLAINT OF STOPCOCK FAILING DURING USE COULD NOT BE CONFIRMED DUE TO THE PRODUCT WAS NOT RETURNED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    A PHYSICIAN IN THE CATH LAB REPORTED THE STOPCOCK IS FALLING APART WITH A CERTAIN AMOUNT OF ATMOSPHERES (PSI). THE CUSTOMER ALSO NOTED THE PRODUCT FAILS AT 40PSI. THERE WAS NO REPORT OF PATIENT HARM OR MEDIAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572806 ALARIS 3-WAY STOPCOCK FMG ELCAM MEDICAL ACAL 10012463 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK