BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER

    MDR report key: 4381452 · Received January 2, 2015

    Report

    Report Number
    3007966929-2014-00138
    Event Type
    Malfunction
    Date Received
    January 2, 2015
    Date of Event
    November 28, 2014
    Report Date
    December 3, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    EXR
    PMA / PMN Number
    K896732
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. THE FACILITY WAS UNABLE TO DETERMINE THE LOT NUMBER FOR THE DEVICE INVOLVED BUT, INDICATED THE DEVICE MAY HAVE BEEN FROM LOT 162157 OR 161560. ADDITIONAL PATIENT AND EVENT DETAILS HAVE BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED THE UNOMETER SAFETI PLUS WAS ATTACHED TO THE PATIENT'S CATHETER ON (B)(6) 2014 AND REPEATEDLY DISCONNECTED FROM THE CATHETER STARTING AROUND 09:00 PM THAT EVENING. THE HEALTH CARE PROFESSIONAL REPORTED WHEN RECONNECTING THE UNOMETER SAFETI PLUS TO THE CATHETER THE NURSES ENSURED THAT THERE WAS A FIRM CONNECTION. THE UNOMETER SAFETI PLUS WAS DISCONTINUED FROM THE PATIENT AROUND 12:00 PM ON (B)(6) 2014, AFTER APPROXIMATELY NINE (9) HOURS OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    958 UNOMETER SAFETI PLUS - WITH LUER-LOCK AND LUER URINOMETER, MECHANICAL EXR UNOMEDICAL LTD. 158101310190

    Patients

    Seq Age Sex Outcome Treatment
    1