BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS G LARGE W/SOFT PORT

    MDR report key: 3765981 · Received April 23, 2014

    Report

    Report Number
    3006760724-2014-00282
    Event Type
    Malfunction
    Date Received
    April 23, 2014
    Date of Event
    April 4, 2012
    Report Date
    April 21, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K110647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BY SMITH & NEPHEW AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS, INCLUDING ADVERSE EVENTS, AS PART OF CORRECTIVE AND REMEDIATION ACTIONS FOLLOWING THE ISSUANCE OF THE 483 ISSUED (B)(4) 2013 TO SMITH & NEPHEW, INC. (B)(4). SMITH & NEPHEW IS PERFORMING A TWO-YEAR RETROSPECTIVE REVIEW OF COMPLAINT FILES TO RE-ASSESS REPORTABILITY CRITERIA AND REPORTING DECISIONS MADE FOR COMPLAINTS RECORDED DURING THE TIME PERIOD UNDER REVIEW. THIS COMPLAINT HAS BEEN RE-ASSESSED IN ACCORDANCE UNDER THE PROVISIONS OF 21CFR 803.50 AND DEEMED REPORTABLE AS AN MDR. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A, FOR A PURPORTED DEVICE MALFUNCTION WHICH OCCURRED WHILE USING THE RENASYS G LARGE W/SOFT PORT. SMITH & NEPHEW RECEIVED THE ABOVE REPORTED COMPLAINT FOR AN ADVERSE EVENT. NO PICTURES, NO SAMPLES AND NO LOT NUMBER INFORMATION WERE PROVIDED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW INVESTIGATION COULD NOT BE INITIATED WITH THE LIMITED PRODUCT INFORMATION PROVIDED, THEREFORE, THE COMPLAINT IS DEEMED UNCONFIRMED. THE COMPONENTS OF THE RENASYS GAUZE KIT (P/N 66800935) THAT COME INTO CONTACT WITH THE WOUND (I.E. GAUZE, SALINE, SOFT PORT, TRANSPARENT FILM) ARE PROVIDED STERILE. STERILITY IS GUARANTEED UNTIL THE PROTECTIVE PACKAGE IS OPENED BEFORE USE. THE VISUAL APPEARANCE OF A BLUE/GREEN COLOUR WITHIN THE RENASYS SOFT PORT OR GAUZE SUPPORTS A CONCLUSION THAT PSEUDOMONAS SPECIES HAS COLONISED THE WOUND. THE COLOUR IS FROM A PIGMENT CREATED BY THE PSEUDOMONAS SPECIES CALLED PYOCYANIN. BLUE/GREEN COLORATION IS NOT SEEN IN CLEAR PLASTIC TUBING BECAUSE THE PIGMENT DOES NOT ADHERE, THEREFORE, IF THE WOUND IS TREATED WITH THE CONVENTIONAL PORT WITH CLEAR TUBE AND INFECTED WITH PSEUDOMONAS, IT WOULD NOT BE DETECTED. THE WHITE COLOUR OF THE SOFT PORT MAKES THE BLUE/GREEN COLOURING MORE VISIBLE WHEN COMPARED TO A TUBE. THIS IS A POSITIVE FEATURE OF THE DEVICE AND SERVES AS A VISUAL INDICATOR IN ROUTINE, ON-GOING CLINICAL ASSESSMENT OF THE PATIENT¿S THERAPY.

    Description of Event or Problem · 1

    INFECTION: NURSE CALLED STATED 2 PATIENTS THAT WERE SWITCHED FROM LARGE GAUZE PORT DRESSING TO LARGE GAUZE PORT SOFT DRESSING DEVELOPED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246548 RENASYS G LARGE W/SOFT PORT PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA SMITH & NEPHEW WOUND MANAGEMENT 66800935 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other