BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD CWS 400 CLOSED WOUND SUCTION KIT

    MDR report key: 1141063 · Received August 29, 2008

    Report

    Report Number
    1018233-2008-00061
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    July 23, 2008
    Report Date
    August 28, 2008
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED ONE USE EVACUATOR WITH PVC DRAIN AND TUBING; ALL COMPONENTS WERE GROSSLY CONTAMINATED WITH BLOOD CLOTS AND BLOOD RESIDUE BOTH INSIDE AND OUTSIDE OF THE COMPONENTS, INCLUDING THE DRAIN EYES OF THE PVC DRAIN. THE EVACUATOR WAS RECEIVED IN A COMPRESSED STATE. THE EVACUATOR WAS VISUALLY INSPECTED UNDER MAGNIFICATION FOR A WEEK/OPEN SEAL OR OVERSEALED AREA AND IT WAS NOTED THE EVACUATOR WAS PROPERLY SEALED AND NO MFG ISSUES WERE OBSERVED. VERIFIED PORT "A" AND "PORT B" WERE VOID OF ANY MFG DEFECTS BUT BOTH PARTS WERE CLOGGED WITH BLOOD RESIDUE AND CLOTS. THE ENTIRE TOP PLATE WAS INSPECTED FOR DAMAGES, RUPTURES, AND TEARS, AND NO MFG ISSUES WERE OBSERVED. AFTER VISUAL INSPECTION, ATTEMPTED TO PERFORM A FUNCTIONAL TEST BY COMPRESSING THE EVACUATOR AND CLOSING PORT "B" AND INTRODUCING THE TUBING INTO A WATER CONTAINER; NONE OF THE WATER WAS SUCTIONED BY THE EVACUATOR. THE TUBING WAS DETACHED FROM THE EVACUATOR AND IN-HOUSE TUBE OF THE SAME SIZE WAS ATTACHED TO THE EVACUATOR AND THE SUCTION TEST WAS REPEATED WITH THE SAME RESULTS OF NO SUCTION. THE TUBING WAS DISCONNECTED FROM THE EVACUATOR AND THE EVACUATOR WAS COMPRESSED AGAIN AND PORT "B" WAS CLOSED, THE EVACUATOR DID NOT DECOMPRESS DUE TO THE CONDUIT WHERE THE TUBING HAS TO BE ATTACHED (PORT "A" 90 DEGREES) WAS CLOGGED WITH BLOOD CLOTS/RESIDUES. THE EVACUATOR WAS DISSECTED IN ORDER TO VERIFY THE CONDITION OF THE EVACUATOR COMPONENTS AND THE VALVE WAS FOUND TO BE TOTALLY CLOGGED. THIS CONDITION ALONE WOULD PREVENT THE EVACUATOR FROM SUCTIONING. THE EVALUATION CONCLUDED THAT THE SAMPLE CONDITION WAS A RESULT OF FAILURE TO FOLLOW LABELING INSTRUCTIONS WHICH REQUIRED FREQUENT INSPECTIONS OF THE AMOUNT AND TYPE OF DRAINAGE FLUID IN THE EVACUATOR AND TO IRRIGATE AND ASPIRATE WOUND AND EVACUATOR IF FLUID EVACUATION IS DIMINISHED. DEVICE FUNCTIONED ACCORDING TO SPECIFICATIONS PRIOR TO BECOMING CLOGGED. 'L'. BASELINE REPORT PREVIOUSLY FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED WITH AN EMERGENT PROCEDURE AND WAS ALREADY INTUBATED UPON ARRIVAL IN OR. A LEFT CRANIOTOMY WAS PERFORMED FOR EVACUATION OF ACUTE SUBDURAL HEMATOMA. PRIOR TO CLOSING THE WOUND AND AT THE END OF THE PROCEDURE, A WOUND DRAIN WAS PLACED AND INITIAL FLOW WAS STARTED. THE EVACUATOR WAS SQUEEZED AND CAPPED TO ALLOW FOR SUCTION. INITIAL DRAINAGE WAS REPORTEDLY VERIFIED IN OR. IT IS NOT KNOW HOW LONG THE SYSTEM FUNCTIONED BUT AFTER ONLY RECEIVING 20ML OF OUTPUT OVER A COMPLETE SHIFT, THE SURGEON SURMISED THAT THE DRAIN WAS CLOGGED. IT IS ALSO UNK AS TO WHAT METHODS MAY HAVE BEEN PERFORMED TO RE-START DRAINAGE PRIOR TO TAKING THE PT BACK TO SURGERY, IF ANY. THE PT REPORTEDLY EXPERIENCED SWELLING OF THE HEAD AND WAS RETURNED TO OR FOR CRANIOTOMY WITH EVACUATION OF HEMATOMA. NO ADDITIONAL INFO HAS BEEN PROVIDED ON THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD CWS 400 CLOSED WOUND SUCTION KIT GCY C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention