BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 2904127 · Received January 3, 2013

    Report

    Report Number
    1820334-2013-00044
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    October 19, 2012
    Report Date
    December 4, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - BLOOD LOSS IS NOT LISTED IN THE INSTRUCTIONS FOR USE. (B)(4) - FAILURE OF VALVE IS NOT LISTED IN THE INSTRUCTIONS FOR USE. THIS EVENT WAS DETERMINED TO BE REPORTABLE DUE TO INFO RECEIVED FROM THE DEVICE EVAL ON (B)(4) 2012. A VISUAL EXAMINATION NOTED THE CHECK-FLO ASSEMBLY WAS MISSING FROM THE PROXIMAL END OF THE COMPLAINT SHEATH. QC (QC) IN-PROCESS INSPECTION PERFORMS AN AIR PRESSURE TEST ON 100% OF EACH ORDER RECEIVED. QC CHECK-FLO INTRODUCER, IN-PROCESS AND FINAL INSPECTION INSPECTS 100% INSPECTION BY CONFIRMING CORRECT PROXIMAL CHECK-FLO ASSEMBLY. DISC MUST BE CORRECTLY POSITIONED IN CHECK-FLO CAP, ASSEMBLY MUST BE CLEAN AND FREE OF DEBRIS, AND THEY CONFIRM CHECK-FLO FITTINGS ARE FULLY SNAPPED AND SECURE. THIS INCIDENT MAY HAVE OCCURRED AS A RESULT OF TWO SEPARATE SCENARIOS. THIS TYPE OF DAMAGE MAY OCCUR IF, DURING THE MFR PROCESS, THE DISC IS NOT PROPERLY SEATED INTO THE HUB. AS A RESULT, THE DISC MAY DISLODGE DURING THE ATTEMPT TO ADVANCE ANOTHER DEVICE THROUGH THE CHECK-FLO DISC. THE SECOND POSSIBILITY FOR THIS TYPE OF DAMAGE TO OCCUR MAY RESULT IF A BLUNT DEVICE IS FORCED THROUGH THE HUB, DISLODGING THE DISK. IT WAS REPORTED THE PROCEDURE LASTED LONGER AND PT INJURY HAS NOT BEEN CONFIRMED. A RISK ANALYSIS (RA) WAS USED TO EVALUATE THE ASSOCIATED RISK. A VISUAL EXAMINATION NOTED THE CHECK-FLO ASSEMBLY WAS MISSING FROM THE PROXIMAL END OF THE COMPLAINT SHEATH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    THE VALVE OF THE INTRODUCER IS MISMATCHED AT THE END OF THE CATHETER. IMPORTANT BLEEDING. THE PROCEDURE LASTED LONGER. PT INJURY TO BE CONFIRMED. THIS EVENT WAS DETERMINED TO BE REPORTABLE DUE TO INFO RECEIVED FROM DEVICE EVAL ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3753 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK, INC. NA 3522122

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK