BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CANNULA

    MDR report key: 2212745 · Received August 16, 2011

    Report

    Report Number
    3008500478-2011-00133
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 20, 2011
    Report Date
    July 20, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DQR
    PMA / PMN Number
    K894243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND THIS DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. PRODUCT IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    INITIAL EVALUATION: "RECEIVED (1) 22FR CANNULA, MODEL (B)(4), IN SEALED ORIGINAL PACKAGE. CUSTOMER REPORT OF CONTAMINATION WAS CONFIRMED. A THIN FIBER LIKE PARTICULATE WAS FOUND INSIDE THE PACKAGE. THE PARTICULATE APPEARED SHINY AND BLUE IN COLOR. THE PARTICULATE WAS APPROXIMATELY 6 MM LONG. SAMPLE WAS SENT TO CHEMISTRY FOR ANALYSIS. AND PER (B)(4) STUDY, (B)(4), THE IR SPECTRUM OF THE UNKNOWN BLUE FIBER SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLYESTER LIKE MATERIAL." FOLLOW UP INVESTIGATION: THE "HAIR" WAS EVALUATED BY MANUFACTURING ENGINEERING AND QUALITY ENGINEERING AT EDWARDS (B)(4). THE "HAIR" IS FIBER-LIKE AND APPEARS TO BE BLUE IN COLOR. THE FIBER WAS MEASURED USING A TAPPI SIZE ESTIMATION CHART AND WAS LESS THAN 1.50 MM2 WHICH IS WITHIN THE SPECIFICATION LISTED IN THE PROCEDURE. PER (B)(4) STUDY (B)(4) PERFORMED AT EDWARDS (B)(4), "THE IR SPECTRUM OF THE UNKNOWN BLUE FIBER SHOWED SIMILAR ABSORPTION CHARACTERISTICS WHEN COMPARING TO POLYESTER LIKE MATERIAL." THE REPORT OF CONTAMINATION WAS CONFIRMED BY EDWARDS (B)(4); HOWEVER, SINCE THE FIBER WAS REMOVED FROM THE (B)(4) DEVICE AND SENT FOR CHEMICAL ANALYSIS, THE REPORTED ISSUE COULD NOT BE CONFIRMED BY EDWARDS (B)(4). THE (B)(4) DEVICE WAS NOT RETURNED TO EDWARDS (B)(4) AND THEREFORE WAS NOT EVALUATED. EACH (B)(4) DEVICE IS 100% VISUALLY INSPECTED FOR LOOSE PARTICULATE BEFORE BEING SEALED IN THE POUCH. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED, AND NO NON-ROUTINE NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURE OF LOT 58910691. THE ISSUE IS AN ISOLATED INCIDENT AND A QUALITY THRESHOLD HAS NOT BEEN EXCEEDED, THEREFORE A CAPA WILL NOT BE INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE OPENING THE CANNULA, THE PERFUSIONIST NOTICED THE PRESENCE OF A HAIR ON THE CANNULA, IN THE STERILE PACKAGING. THEY DID NOT OPEN THE PACKAGING, AND USED ANOTHER CANNULA INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CANNULA ARTERIAL CANNULA DQR EDWARDS LIFESCIENCES APC022B 58910691

    Patients

    Seq Age Sex Outcome Treatment
    1