BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 1667765 · Received April 23, 2010

    Report

    Report Number
    1317056-2010-00027
    Event Type
    Malfunction
    Date Received
    April 23, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 24, 2010
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    DRS
    PMA / PMN Number
    K951722
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. RETURNED BY THE CUSTOMER WERE 7 UNITS OF THE MANIFOLD/TUBING ASSEMBLY. VISUAL/MICROSCOPIC EXAM: AS RECEIVED, ON ONE OF THE SEVEN UNITS, THE BONDED CONNECTION BETWEEN THE 10" CONTRAST INJECTION LINE (CIL) AND THE MANIFOLD MALE ROTATING ADAPTOR WAS DETACHED AND THE STEM OF THE ROTATING ADAPTER REMAINED INSIDE THE FEMALE LUER OF THE CIL. THE SIX REMAINING ASSEMBLIES APPEARED UNDAMAGED. THE SIX UNDAMAGED ASSEMBLIES WERE PRESSURE TESTED WITH WATER AND DYE INJECTED BY HAND USING A SYRINGE. TWO OF THE ASSEMBLIES LEAKED AT THE BOND SITE OF THE ROTATING ADAPTOR AND THE CIL. THE OTHER 4 ASSEMBLIES WERE LEAK-FREE. THE ROOT CAUSE OF THE LEAKAGE MAY BE ATTRIBUTED TO INSUFFICIENT BONDING AGENT HAVING BEEN APPLIED AT THE CONNECTION. THE EMPLOYEES INVOLVED WITH THE PRODUCTION OF THIS WORK ORDER HAVE BEEN MADE AWARE OF THIS ISSUE AND HAVE BEEN RE-TRAINED ON THE APPLICABLE ASSEMBLY AND INSPECTION PROCEDURES. THE POTENTIAL ROOT CAUSE OF THE DAMAGED ASSEMBLY MAY BE THAT THE END USER ATTEMPTED TO TIGHTEN THE BONDED CONNECTION RESULTING IN BREAKAGE. MANUFACTURING PROCESS CONTROLS FOR THIS ASSEMBLY INCLUDE REQUIREMENTS TO VISUALLY INSPECT ALL BONDS FOR THE APPROPRIATE AMOUNT OF BONDING AGENT AND THAT THE COMPONENTS HAVE BEEN FITTED TOGETHER PROPERLY. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY DISTRIBUTOR IN (B)(4), HOSPITAL EXPERIENCED A LEAK IN THE SEAL (BOND) BETWEEN THE MONITORING MANIFOLD AND THE EXTENSION TUBING RESULTING IN AIR BUBBLES IN THE TUBING. THIS EVENT OCCURRED DURING PREPARATION WHILE FLUSHING THE SYSTEM, THUS NO AIR WAS INJECTED AND THERE WAS NO PATIENT INJURY. THE USED DEVICE HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL TRANSDUCER, BLOOD PRESSURE DRS NAVILYST MEDICAL NA 1370035

    Patients

    Seq Age Sex Outcome Treatment
    1