BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 5018685 · Received August 11, 2015

    Report

    Report Number
    1317056-2015-00142
    Event Type
    Malfunction
    Date Received
    August 11, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 17, 2015
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    OEZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE (B)(6) 215 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE CONVENIENCE KIT PRODUCT FAMILY AND THE FAILURE MODE "AIR BUBBLES NOTED." NO ADVERSE TRENDS WERE IDENTIFIED. ONE USED AND ONE UNUSED STOPCOCK/CONSTRAST INJECTION LINE (CIL) SET WERE RETURNED FOR EVALUATION. THE CONNECTION SITE BETWEEN THE RETURNED STOPCOCK AND CIL APPEARED TO BE FIRMLY ATTACHED, BUT NOT OVER-TIGHTENED. WHEN THE STOPCOCK WAS REMOVED FROM THE CIL, THE STOPCOCK FEMALE LUER LOCK SIDE PORT CONTAINED SLIGHT ROTATIONAL GOUGE MARKS INSIDE THE THREADED AREA. A MICROSCOPIC VISUAL INSPECTION OF THE STOPCOCK FEMALE SIDE PORT WAS PERFORMED FOR ANY DAMAGE, AND IT WAS NOTED THAT THERE WAS A SLIGHT SURFACE CRACK JUST BELOW THE FEMALE THREADS. THE SLIGHT ROTATIONAL GOUGE MARKS AND SURFACE CRACK ARE CONSISTENT WITH PREVIOUSLY VIEWED SAMPLE OF OVER TIGHTENED CONNECTIONS. NO DAMAGE WAS NOTED TO THE UNUSED DEVICES. AN AIR LEAK WAS PERFORMED PER NAVILYST MEDICAL PROCEDURES ON THE CONNECTED STOPCOCK AND CIL AS WELL AS ON EACH COMPONENT, INDIVIDUALLY. NO AIR LEAKAGE OCCURRED. THE FEMALE TAPERS OF THE STOPCOCKS AND THE MALE TAPERS OF THE CILS WERE MEASURED, ALONG WITH THE FEMALE THREADS OF THE STOPCOCKS. ALL DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. THE REPORTED COMPLAINT DESCRIPTION CANNOT BE CONFIRMED. THERE WERE NO MANUFACTURING RELATED DEFECTS NOTED IN RETURNED SAMPLES. THE SAMPLES WERE EVALUATED AND WERE FOUND VISUALLY, DIMENSIONAL AND FUNCTIONALLY ACCEPTABLE. A POSSIBLE ROOT CAUSE MAY BE THAT THE END USER DID NOT ADEQUATELY SECURE CONNECTIONS BETWEEN THE STOPCOCK AND 6'CIL OR THE DEVICE TO WHICH THEY WERE CONNECTING. THE DIRECTIONS FOR USE (DFU) PROVIDED TO THE CUSTOMER IN THE REPORTED KIT CONTAINS THE FOLLOWING STATEMENTS, "ALL CONNECTIONS SHOULD BE FINGER TIGHTENED. OVER TIGHTENING CAN CAUSE CRACKS AND LEAKS TO OCCUR THAT COULD RESULT IN EMBOLISM AND OR EXPOSURE TO BIOHAZARDS. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY NAVILYST MEDICAL'S DISTRIBUTOR IN (B)(4), DURING PREP FOR A PROCEDURE, A HOSPITAL NOTED DIFFICULTY IN DEFLATING AN OZUMA BALLOON. "WHEN NEGATIVE PRESSURE WAS APPLIED PRIOR (TO) USAGE, THIS AIR DRAWING-IN WAS OBSERVED." THE HOSPITAL WAS UTILIZING A CONVENIENCE KIT CONSISTING OF A STOPCOCK AND A 6-CONTRAST INJECTION LINE. THE STOPCOCK MALE FITTING WAS ATTACHED TO THE BALLOON CATHETER, THE STOPCOCK FEMALE FITTING TO AN EVEREST INFLECTION DEVICE, AND THE CONTRAST INJECTION LINE MALE FITTING TO THE BALLOON CATHETER. AS THIS OCCURRED PRIOR TO THE PROCEDURE, THE PATIENT WAS NOT AFFECTED. THE USED DEVICES WERE RETURNED TO NAVILYST MEDICAL FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524431 NAVILYST MEDICAL CONVENIENCE KIT OEZ NAVILYST MEDICAL NA 4838256

    Patients

    Seq Age Sex Outcome Treatment
    1