BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 5915744 · Received August 30, 2016

    Report

    Report Number
    2025816-2016-00118
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Report Date
    July 14, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFG. LOT BUILD REVIEW - A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE THREE "POTENTIAL" LOT NUMBER WAS PERFORMED. THE RESULTS RECORDED LOT# 3265974 (MFG. 05/2016) (B)(4) UNITS; 3200037 (MFG. 03/2016) (B)(4) UNITS AND LOT# 3254636 (MFG. 05/2016) (B)(4) UNITS; ALL MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED. PENDING RECEIPT OF INVOLVED DEVICES.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING LEAKAGE ISSUE WITH USE OF UNSPECIFIED DIALYSIS SET-UPS WHERE D1000 TEGO CONNECTORS WERE IN USE. INITIAL INFORMATION REPORTS THERE HAVE BEEN FOUR INCIDENTS WHERE CLINICIANS FOUND "..TEGO CAPS LEAKING ON THE SIDE DURING HEMODIALYSIS. TREATMENT. STAFF HAS TO INTERRUPT TREATMENT TO CHANGE AFFECTED PRODUCT FOR PATIENT SAFETY." THERE WERE NO REPORTED PATIENT INJURIES AND OR ADVERSE CONSEQUENCES. THE TEGO CONNECTORS WERE REMOVED AND REPLACED WITH NO FURTHER ISSUES ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565023 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1