BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER

    MDR report key: 6017810 · Received October 11, 2016

    Report

    Report Number
    3007966929-2016-00093
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    September 8, 2016
    Report Date
    September 19, 2016
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    FFG
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORDS WERE REVIEWED. NO NON-CONFORMANCE WAS INITIATED. STERILIZATION WAS PERFORMED IN ACCORDANCE WITH PARAMETERS. THE BATCH WAS RELEASED ACCORDING TO REQUIREMENTS. A BATCH RECORD REVIEW INDICATES NO DISCREPANCIES INITIATED DURING PRODUCTION. THE BATCH RECORD REVIEW RESULTED IN A DISCREPANCY WHICH WAS INVESTIGATED IN ANOTHER COMPLAINT AND IS CLOSED. NO ADDITIONAL INVESTIGATION IS NEEDED. A PHOTOGRAPH HAS BEEN RECEIVED FOR THIS COMPLAINT, WHICH WAS EVALUATED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON NOVEMBER 03, 2016. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). EXPIRATION DATE (08/2020). MANUFACTURING DATE (09/2015). BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO DATE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON: OCTOBER 11, 2016. (B)(4).

    Description of Event or Problem · 1

    COMPLAINANT REPORTED THAT A PATIENT IN ICU WAS CAUTERIZED ON (B)(6), WITH A URINARY FOLEY CATHETER AND A UNOMETER SYSTEM. "ON (B)(6), AFTER EIGHT (8) DAYS OF USAGE, THE NURSE OBSERVED SEDIMENT AND BIOFILM IN THE SAMPLING PORT DURING A URINE SAMPLING AND SEDIMENT IN THE MEASURING CHAMBER. THE TUBING OF THE SYSTEM COLLAPSED AFTER BEING VACUUMED AND WAS CHANGED ACCORDING TO THE INSTRUCTIONS OF THE INFECTIONS COMMITTEE." NO FURTHER DETAILS HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668231 UNOMETER¿ SAFETI¿ PLUS - WITH LUER-LOCK & LUER DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE FFG UNOMEDICAL LTD. 158100140190 211912

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR MEDICATIONS: AB CLARITROMICINE, CEFEPIME AND| VANCOMICINE