BEUDAMED
    FDA Adverse Event Injury Summary report: N

    100CC SILICONE BULB EVACUATOR

    MDR report key: 2000977 · Received February 18, 2011

    Report

    Report Number
    1018233-2011-00019
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 21, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD WAS REVIEWED FINDING NOTHING THAT COULD CAUSE OR CONTRIBUTE TO THE REPORTED FAILURE. THE SAMPLE WAS RETURNED FOR EVALUATION FINDING THE FLAT DRAIN TUBE BROKEN AT THE FIRST EYE AT THE BEGINNING OF THE TRANSITION. THE SAMPLE WAS EXAMINED UNDER MAGNIFICATION FINDING NO EVIDENCE OF ANY PUNCTURES. THE BROKEN SURFACE HAD JAGGED EDGES WHICH IS INDICATIVE OF EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DRAIN BEYOND ITS TENSILE CAPABILITIES. THERE IS NOTHING IN THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS "ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. AVOID SUTURING THROUGH DRAIN. DRAIN SHOULD LIE FLAT AND IN LINE WITH THE SKIN EXIT AREAS. PARTICULAR CARE SHOULD BE TAKEN TO AVOID ANY OBSTACLES TO THE DRAIN EXIT PATH. DRAIN SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAIN SHOULD NOT BE HANDLED WITH POINTED, TOOTHED OR SHARP INSTRUMENTS WHICH COULD CAUSE CUTS OR NICKS AND LEAD TO SUBSEQUENT STRUCTURAL FAILURE OF THE DRAIN." AN ADDITIONAL WARNING STATES: "DRAIN BREAKAGE MAY REQUIRE SURGICAL REMOVAL." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN ATTEMPTING TO REMOVE THE DRAIN FROM THE LEFT KIDNEY, THE DRAIN BROKE. THERE WAS MINIMAL RESISTANCE REPORTED WHILE REMOVING THE DRAIN. THE PATIENT WAS TAKEN TO SURGERY FOR REMOVAL OF THE RETAINED PIECE. THE PORTION OF THE DRAIN REMOVED WAS MATCHED TO THE REMAINING PORTION OF THE DRAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 100CC SILICONE BULB EVACUATOR GBX C.R. BARD, INC. NA NGUG2323

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention