BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH LAB KIT

    MDR report key: 6909395 · Received October 3, 2017

    Report

    Report Number
    2025816-2017-00181
    Event Type
    Malfunction
    Date Received
    October 3, 2017
    Date of Event
    June 26, 2017
    Report Date
    July 24, 2017
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    DQO
    UDI-DI
    00887709049628
    PMA / PMN Number
    K052865
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 3407711 (MFG. 03/2017) SHOWED (B)(4) UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. THE 46098-75 KIT DEVICE/COMPONENTS WERE PRE-TESTED/PRIMED PRIOR TO PLACEMENT, AT A UNSPECIFIED TIME THE PRODUCT ISSUE (PARTICULATE) WAS DETECTED BY ATTENDING CLINICIAN. THE DEVICE WAS REMOVED/REPLACED. ALTHOUGH THERE WAS AN UNSCHEDULED DEVICE CHANGE OUT THERE WAS NO CRITICAL DELAY IN THERAPY; NO CHANGE IN PTS. BASELINE CONDITION AND OR NO EMERGENT MEDICAL TREATMENTS AND OR INTERVENTIONS WERE REQUIRED. THE INVOLVED DEVICE/COMPONENT WERE NOT RETURNED FOR ANALYSIS AND CONFIRMATION. THE EXACT CAUSE(S) OF THE REPORTED EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    VOLUNTARY EVENT REPORT MW 5070799 RECEIVED REPORTING PARTICULATE ISSUE(S) WITH USE OF ONE 46098-75 CATH LAB KIT. THE MW 5070799 REPORT DESCRIBES THE (B)(6) 2017 EVENT AS FOLLOWS ".. DURING A PROCEDURE, THE PHYSICIAN NOTED A SMALL PIECE OF PLASTIC IN THE FLUID AFTER HE HAD PULLED BACK ON THE SYRINGE WHICH WAS ATTACHED TO THE MANIFOLD. ORIGIN OF THE PLASTIC IS UNK BUT MAY HAVE ORIGINATED IN THE MANIFOLD. SYRINGE APPEARS INTACT." ALTHOUGH ADDITIONAL EVENT INFORMATION AND DEVICE RETURN STATUS WERE REQUESTED FACILITY HAD NO ADDITIONAL EVENT INFORMATION OR THE LOCATION / STATUS OF THE INVOLVED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689291 CATH LAB KIT CATH LAB KIT DQO ICU MEDICAL INC. 46098-75 3407711 00887709049628

    Patients

    Seq Age Sex Outcome Treatment
    1