BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ISO-GARD FILTER STRAIGHT

    MDR report key: 3915392 · Received May 28, 2014

    Report

    Report Number
    8040412-2014-00117
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES A LEAK IN THE ANESTHETIC MACHINE. THE CUSTOMER REPORTS THAT THE SOURCE OF THE LEAK WAS A SLIVER OF PLASTIC WHICH WAS BETWEEN TWO CONNECTORS PREVENTING THEM FROM CONNECTING. THE ALLEGED ISSUE WAS DETECTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314623 HUDSON ISO-GARD FILTER STRAIGHT FILTER CAH TELEFLEX MEDICAL 19212T

    Patients

    Seq Age Sex Outcome Treatment
    1