BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOCK PERICARDIOCENTESIS CATHETER SET

    MDR report key: 2860158 · Received November 30, 2012

    Report

    Report Number
    1820334-2012-00538
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). AS OF (B)(4) 2012 NO PRODUCT HAS BEEN RETURNED. FINAL INSPECTION FOR PERICARDIOCENTESIS CATHETER CONFIRMS OVERALL SURFACE OF CATHETER IS CLEAN, SMOOTH AND FREE OF DAMAGE. THE PRODUCT IS SHIPPED WITH AN INSTRUCTIONS FOR USE (IFU) STATING PRECAUTIONS AND INSTRUCTIONS FOR USE. UNDER "INSTRUCTIONS FOR USE" STEP 10: "ADVANCE THE CATHETER INTO THE PERICARDIUM." STEP 11: "REMOVE THE WIRE GUIDE." STEP 12: "ATTACH THE CONNECTING TUBE TO THE CATHETER AND ASPIRATE." WITHOUT THE PRODUCT BEING RETURNED IT IS INCONCLUSIVE ON HOW THE DEVICE COULD HAVE CONTRIBUTED TO THE FAILURE MODE. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE CONCLUSION OF THE RISK ASSESSMENT, RISK MITIGATING ACTION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE DRAIN HAS BROKEN OFF WHERE IT CONNECTS TO THE 3 WAY TAP. THE DRAIN THEN MIGRATED UNDER THE SKIN AND INTO THE PATIENT THE PRODUCT IS NOW BEING RETRIEVED FROM THE PATIENT. NO ADDITIONAL INFORMATION OR PATIENT OUTCOME HAS BEEN PROVIDED TO ASSIST IN THIS INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCK PERICARDIOCENTESIS CATHETER SET DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 2854448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention