BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD 100CC SILICONE BULB EVACUATOR 0070740

    MDR report key: 1950588 · Received December 28, 2010

    Report

    Report Number
    MW5018752
    Event Type
    Injury
    Date Received
    December 28, 2010
    Date of Event
    December 11, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BARD MEDICAL
    Product Code
    GCY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD TOTAL KNEE REPLACEMENT. DURING SURGERY, A DRAIN WAS PLACED WITH AN EVACUATOR BULB. WHEN DRAIN REMOVED, NOTICED TIP OF DRAIN WAS MISSING. SURGEON NOTIFIED AND X-RAY TAKEN. X-RAY SHOWED SOFT TISSUE SWELLING AND RADIOPAQUE FOREIGN BODY IN THE ANTERIOR ASPECT OF THE DISTAL FEMUR. PT HAD TO RETURN TO SURGERY TO HAVE TIP OF DRAIN REMOVED. PT DID WELL AND WAS DISCHARGED THE FOLLOWING DAY. THIS SAME ISSUE HAPPENED WITH ANOTHER PT -DR (B)(6)- IN NOVEMBER, BUT I WAS NOT MADE AWARE OF IT UNTIL THIS OCCURRENCE. THE DRAIN WAS USED FOLLOWING LUMBAR LAMINECTOMY. PT HAD TO BE READMITTED ON (B)(6) 2010, FOR REMOVAL OF FOREIGN BODY. I HAVE NO INFO ON LOT# BUT COULD POSSIBLY BE THE SAME AS THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 100CC SILICONE BULB EVACUATOR 0070740 JACKSON PRATT DRAIN GCY BARD MEDICAL NGUH3478 OR NGUE0582

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| S