BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL-PORT

    MDR report key: 5676835 · Received May 24, 2016

    Report

    Report Number
    1820334-2016-00331
    Event Type
    Injury
    Date Received
    May 24, 2016
    Date of Event
    April 28, 2016
    Report Date
    April 29, 2016
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LJT
    UDI-DI
    00827002264342
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME: VITAL-PORT ATTACHED SILICONE CATHETER WITH INT TITANIUM POWER INJECTABLE PORT. COMMON DEVICE NAME: LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL. (B)(4). 510(K) #: K150733. INVESTIGATION / EVALUATION. NO IMAGES NOR DEVICE WERE RETURNED; HOWEVER, DURING THE COURSE OF INVESTIGATION, A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD AND DOCUMENTATION WAS CONDUCTED. A REVIEW OF MANUFACTURING RECORDS AND ALL PROCESS PARAMETERS WERE FOUND TO BE WITHIN SPECIFICATIONS, NO DEVIATIONS WERE FILED FOR THE STERILIZATION RUN, NO ANOMALIES WERE FOUND IN TEMPERATURE, CONCENTRATION, AND NO DAMAGE WAS OBSERVED ON PRODUCT RETURNED FROM STERILIZATION. THERE ARE NO SIGNS OF A STERILITY FAILURE. AS NO PRODUCT WAS RETURNED AND BASED ON THE LIMITED INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE WITH CERTAINTY THE ROOT CAUSE OF THIS COMPLAINT. PER THE QUALITY ENGINEERING RISK ASSESSMENT (QERA) NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR THIS DEVICE.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT THE VITAL-PORT WAS INSERTED ON (B)(6) 2016 AND REMOVED ON THE (B)(6) 2016 FROM THE (B)(6) FEMALE PATIENT WITH PRE-EXISTING CONDITION OF CANCER, DUE TO WHAT APPEARED TO BE SIGNS OF INFECTION OR A REACTION. THE PHYSICIAN STATED THAT THE PATIENT WAS NOT IMMUNOSUPPRESSED NOR HAD ALLERGIES. HOWEVER, THE PATIENT HAD REDNESS AT THE PORT POCKET, THE TUNNELED TRACT AND ALSO AT THE INSERTION SITE. THE WOUND PORT POCKET SITE ALSO DISPLAYED SIGNS OF WEEPING; THEREFORE, THE PATIENT COULD NOT RECEIVE HER CHEMO TREATMENT. THE PORT WAS REMOVED AND SENT TO THE FACILITY'S PATHOLOGY DEPARTMENT. FOR CULTURE. NO UNEXPECTED PART OF THE DEVICE REMAINED INSIDE THE PATIENT; HOWEVER, THE PATIENT WILL REQUIRE AN ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE; PATIENT WAS GIVEN CEPHAZOLON ANTIBIOTICS AND PORT IS BEING REMOVED WITH THE NEXT 24 HOURS. THE INITIAL REPORTER DID NOT SPECIFY ANY ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS EVENT, HOWEVER THE DESCRIPTION OF EVENT STATES: PATIENT HAD REDNESS AT AND ABOVE THE PORT POCKET AND WAS WARM TO TOUCH BUT NOT BELOW, THERE WAS ALSO REDNESS AT THE INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330762 VITAL-PORT LJT COOK VASCULAR INC N/A 00827002264342

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention