BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HENORA 300PSI I.V. CATHETER EXTENSION SET

    MDR report key: 3834781 · Received March 20, 2014

    Report

    Report Number
    3004994611-2014-00002
    Event Type
    Malfunction
    Date Received
    March 20, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 19, 2014
    Manufacturer
    RGI MEDICAL MANUFACTURING INC.
    Product Code
    GCD
    PMA / PMN Number
    K952470
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN DIFFICULTIES COMMUNICATING WITH THE HEALTH CARE PROVIDER ABOUT THE RETURN OF THE DEVICE. NUMEROUS ATTEMPTS HAVE BEEN MADE BY TELEPHONE AND E-MAIL TO CONTACT THE HEALTH CARE PROVIDER TO OBTAIN ADDITIONAL INFORMATION AND THE MANUFACTURER IS STILL ATTEMPTING TO ACQUIRE THE DEVICE FOR TESTING. A FOLLOW UP REPORT WILL BE PROVIDED WHEN THE DEVICE IS RETURNED FOR TESTING. THE LOT NUMBER/DATE OF MANUFACTURE WAS NOT KNOWN BECAUSE THE DEVICE PACKAGING HAD BEEN DISCARDED PRIOR TO THE DEVICE ISSUE.

    Description of Event or Problem · 1

    THE CATHETER EXTENSION SET HAD BEEN PREVIOUSLY PUT IN PLACE ON THE PATIENT BY EMERGENCY ROOM STAFF AT AN EARLIER TIME. DURING THE NIGHT, WHILE MAKING THE NORMAL ROUNDS ON PATIENT, THE NURSE FOUND THAT THE CATHETER EXTENSION SET HAD COME APART AT THE CONNECTIN TO THE HEP LOCK CAP. THE NURSE ESTIMATED THAT THE PATIENT HAD LOST AROUND 300-400 ML OF BLOOD. THE I.V. WAS RESTARTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165378 HENORA 300PSI I.V. CATHETER EXTENSION SET INTRAVENOUS EXTENSION TUBING SET GCD RGI MEDICAL MANUFACTURING INC. NA NOT AVAILABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention