BEUDAMED
    FDA Adverse Event Other Summary report: N

    DRAIN SIL RND END PERF 10FR W/

    MDR report key: 1851716 · Received September 28, 2010

    Report

    Report Number
    1417592-2010-00059
    Event Type
    Other
    Date Received
    September 28, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 21, 2010
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A SURGICAL PROCEDURE HAD BEEN CONDUCTED ON A SHOULDER. THE DRAIN HAD BEEN PLACED DURING THE PROCEDURE WITH THE INTENT THAT IT BE REMOVED IN THE RECOVERY ROOM. UPON REMOVAL, IT WAS REPORTED TO FEEL 'A LITTLE SNUG'. WHEN THEY REMOVED IT, THEY REALIZED THAT A PIECE WAS RETAINED. THE SURGEON REMOVED THE RETAINED PIECE WITH THE ASSISTANCE OF AN INSTRUMENT. HE WAS NOT TAKEN BACK TO THE OPERATING ROOM AND IT DID NOT REQUIRE ANY SURGICAL INTERVENTION. THE PT WAS REPORTED TO DO WELL AND WAS SUBSEQUENTLY DISCHARGED. THE RETAINED PIECE WAS ESTIMATED TO BE 5 3/4 INCHES LONG. THE SAMPLE WAS EVALUATED BY MFG. THEY CONFIRMED THAT THE BROKEN AREA WAS DIAGONAL AND 'TOOTHED'. THEY DETERMINED THAT MECHANICAL DAMAGE WAS THE SOURCE OF THE BREAK AND THAT IT MOST LIKELY WAS DAMAGED BY SOME SHARP OBJECT DURING INSERT OR REMOVAL. WHEN OTHER DRAINS WERE TESTED FOR TENSILE STRENGTH (TORN ARTIFICALLY), THE TEAR WAS ALWAYS STRAIGHT. THE JAGGED APPEARANCE OF THE BROKEN RETURNED SAMPLE SUGGESTS THAT THE DRAIN WAS MECHANICALLY DAMAGED AND THEN BROKE. AT THIS TIME NO CORRECTIVE ACTION IS INDICATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SURGICAL DRAIN BROKE UPON REMOVAL AND THE RETAINED PIECE WAS REMOVED WITH AN INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAIN SIL RND END PERF 10FR W/ NONE GCY MEDLINE INDUSTRIES, INC. DYNJWE0321 P1001799

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention