BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 2943832 · Received January 30, 2013

    Report

    Report Number
    1820334-2013-00047
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    December 31, 2012
    Report Date
    January 3, 2013
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BLOOD LOSS IS NOT LISTED IN THE INSTRUCTION FOR USE. VALVE LEAK IS NOT LISTED IN THE INSTRUCTIONS FOR USE. INTRODUCER WAS RETURNED IN USED AND DAMAGED CONDITION: THE CHECK-FLO VALVE CAP HAD SEPARATED FROM THE CHECK-FLO VALVE BODY WITH THE SILICONE DISC REMAINING IN THE CAP. THE CHECK-FLO VALVE CAP AND SILICONE DISC HAD SEPARATED FROM THE CHECK-FLO VALVE BODY. NEITHER THE CAP NOR THE BODY WAS DAMAGED AND BOTH PARTS WERE ABLE TO BE PRESSED TOGETHER WITH HAND-APPLIED PRESSURE. QUALITY CONTROL SPECIFICATION INSTRUCTS 100% INSPECTION AS FOLLOWS, "CONFIRM CORRECT PROXIMAL CHECK-FLO ASSEMBLY. DISC MUST BE CORRECTLY POSITIONED IN CHECK-FLO CAP. ASSEMBLY MUST BE CLEAN AND FREE OF DEBRIS. CONFIRM CHECK-FLO FITTINGS ARE FULLY SNAPPED AND SECURE." PRECAUTIONS LISTED IN THE INSTRUCTIONS FOR USE STATE, "THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE ITS PASSAGE THROUGH THE INTRODUCER. ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT." THE MIS-ASSEMBLED VALVE RESULTED IN BLOOD LOSS TO THE PT; HOWEVER, NO MEDICAL INTERVENTION AS A RESULT OF THIS INCIDENT WAS REPORTED. COMPLAINT CONFIRMED BASED ON CUSTOMER'S STATEMENTS OF THE EVENT AND VISUAL INSPECTION OF THE RETURNED DEVICE WHICH REVEALED THAT WHILE THE VALVE COMPONENTS HAD SEPARATED, THEY WERE NOT DAMAGED AND COULD NOT BE PRESSED TOGETHER AND FUNCTION PROPERLY. BASED ON THE INFORMATION PROVIDED, THE VALVE CAP AND BODY WERE NOT PROPERLY ASSEMBLED RESULTING IN VALVE FAILURE AND PT BLEEDING; HOWEVER, NO MEDICAL INTERVENTION AS A RESULT OF THE BLEEDING WAS REPORTED. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE CONTINUE TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. RISK ASSESSMENT WAS PERFORMED BY QUALITY ENGINEERING FOR THIS FAILURE MODE AND PRODUCT FAMILY AND CONCLUDED WITH THE ADDITION OF THIS EVENT, NO RISK MITIGATION ACTIVITIES ARE NECESSARY AND THE RISK TO PT REMAINS ACCEPTABLE.

    Description of Event or Problem · 1

    THE VALVE ON THE INTRODUCER FAILED DURING THE PROCEDURE, CAUSING A HUGE BLEEDING. NO SPECIFIC INCIDENT DATE, HAPPENED DURING (B)(6). ALTHOUGH REQUESTED, MORE INFORMATION HAS NOT BEEN PROVIDED BY THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41706 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK, INC. NA 3682012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other