BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICONE ROUND DRAIN

    MDR report key: 3221764 · Received July 5, 2013

    Report

    Report Number
    MW5030830
    Event Type
    Injury
    Date Received
    July 5, 2013
    Date of Event
    June 27, 2013
    Report Date
    July 5, 2013
    Manufacturer
    CR BARD INC
    Product Code
    GBX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING THE ROUND DRAIN FROM THE SURGICAL SITE, THE NURSE FELT RESISTANCE. BULB WAS INFLATED AND DEFLATED, BUT STILL MET RESISTANCE. NURSE ATTEMPTED AGAIN TO REMOVE AND FELT THE TUBE ON THE DEVICE SNAP. THE DISTAL TIP, APPROX 3 CM, WAS RETAINED IN THE PT'S KNEE. SURGICAL REMOVAL WAS NECESSARY, INCREASING THE PT'S LENGTH OF STAY. REASON FOR USE: DRAIN FOR SURGICAL SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307598 SILICONE ROUND DRAIN JP DRAIN GBX CR BARD INC NGTF0281
    307599 SILICONE ROUND DRAIN JP DRAIN GBX CR BARD INC NGWJ2494

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization