BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL, BIOFLO

    MDR report key: 4170346 · Received September 30, 2014

    Report

    Report Number
    1317056-2014-00058
    Event Type
    Injury
    Date Received
    September 30, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 9, 2014
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K131694
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE HISTORY RECORDS FOR THE REPORTED PORT PACKAGING TRAY LOT SHOWS THAT THE TRAY SEALING PARAMETERS DOCUMENTED FOR TEMPERATURE, TIME AND PRESSURE WERE CORRECT PER NAVILYST MEDICAL PROCEDURES. IN ADDITION, SEAL CHECK (VISUAL) AND TRAY BURST TESTING WAS PERFORMED ON BOTH THE INNER AND OUTER TRAYS. THIS TRAY TESTING WAS PERFORMED PRE-PRODUCTION AND POST-PRODUCTION THERE WERE NO OUT OF SPECIFICATION CONDITIONS; ALL TESTING PASSED. NO NON-CONFORMANCES WERE WRITTEN AGAINST THE REPORTED PACKAGING LOT RELATED TO PORT TRAY SEAL ISSUES. IN ADDITION, THERE HAVE BEEN NO NON-CONFORMANCES WRITTEN AGAINST THE PORT ASSEMBLY LOTS OR CATHETER TUBING COMPONENT LOT FOR ANY ISSUES THAT WOULD CONTRIBUTE TO A FAILURE MODE OF PATIENT INFECTION. STERILIZATION RECORDS WERE REVIEWED FOR THE PORT PACKAGING LOT AND THERE WERE NO NON-CONFORMANCES REPORTED FOR THIS STERILE LOAD. THE (B)(4) 2014 NAVILYST MEDICAL COMPLAINT REPORT WAS REVIEWED FOR THE BIOFLO PORT PRODUCT FAMILY FOR THE FAILURE MODE "PATIENT INJURY" INFECTION. NO ADVERSE TRENDS WERE IDENTIFIED. THE ROOT CAUSE OF THE PT INFECTION IS UNABLE TO BE DETERMINED, AND THERE IS NO EVIDENCE THAT THE MANUFACTURING, PACKAGING, OR STERILIZATION OF THE BIOFLO PORT CONTRIBUTED TO THE EVENT. POTENTIAL CONTRIBUTING FACTORS FOR PATIENT INFECTIONS INCLUDE THE PORT PLACEMENT PROCEDURES AND DEVICE CARE AND MAINTENANCE. THE DIRECTIONS FOR USE PACKAGED WITH THE DEVICE CAUTIONS THAT THE INTEGRITY OF THE DEVICE PACKAGING SHOULD BE EXAMINED BEFORE USE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, PT WITH ASTHMA, HYPERTENSION, BREAST CANCER AND DIABETES WAS IMPLANTED IN THEIR RIGHT CHEST WITH A BIOFLO PORT FOR CHEMOTHERAPY ON (B)(6) 2014 AND DEVELOPED A POST-OPERATIVE INFECTION. THE PORT WAS REMOVED ON (B)(6) 2014. FOLLOW-UP INFO RECEIVED FROM THE HOSPITAL HAS INDICATED THAT THE PT IS IN STABLE CONDITION. THE USED PORT WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606886 NAVILYST MEDICAL, BIOFLO PORT, INTERNAL, SUBCUTANEOUS LJT NAVILYST MEDICAL NA 4688883D

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention