BEUDAMED
    FDA Adverse Event Other Summary report: N

    400CC EVACUATION W/ 10FR, 1/8"

    MDR report key: 1003822 · Received February 26, 2008

    Report

    Report Number
    1417592-2008-00004
    Event Type
    Other
    Date Received
    February 26, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 22, 2008
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ON THE SECOND POST OP DAY, ONE OF THE SURGEON'S ASSOCIATES CAME IN TO REMOVE THE DRAINS FROM THE KNEES. ONE CAME OUT WITHOUT DIFFICULTY BUT THE OTHER ONE DID NOT. THE SURGEON CAME IN THE NEXT DAY AND PULLED ON IT AGGRESSIVELY UNTIL IT CAME OUT BUT BROKE IN THE PROCESS. A PIECE WAS LEFT INSIDE THE PT. THE PT WAS TAKEN BACK TO SURGERY THAT DAY AND THE PIECE WAS SUCCESSFULLY REMOVED. IT IS UNK IF SUTURING TOOK PLACE IN NEAR PROXIMITY TO THE DRAIN. THERE WERE NO OTHER COMPLICATIONS NOTED. THE FACILITY PROVIDED THE SAMPLE FOR VISUAL INSPECTION ONLY. THE RETURNED SAMPLE INCLUDED THE EVACUATOR AND THE ATTACHED DRAIN. THE PIECE OF THE DRAIN WHICH BROKE INSIDE THE PT WAS NOT RETURNED FOR EVALUATION. THE SAMPLE HAD A JAGGED BREAK WHICH OCCURRED ON THE SECTION OF THE DRAIN WITH HOLES BUT THE BREAK DID NOT OCCUR AT AN ACTUAL DRAIN HOLE LOCATION. THERE WAS NO EVIDENCE OF A CLEAR PUNCTURE TO THE DRAIN AND NO DEFORMITIES WERE NOTED. SAMPLES WERE THEN TAKEN FROM STOCK AND TESTED. THE PURPOSE OF THE TEST WAS TO DETERMINE THE FORCE NEEDED TO BREAK THE DRAIN IN LOCATIONS WITH AND WITHOUT HOLES WHEN THE DRAIN HAS NOT BEEN DAMAGED OR ALTERED AS WELL AS TO DETERMINE THE PATTERN OR TEXTURE OF THE DRAIN AT THE POINT OF BREAKAGE. THE RESULTING BREAKS WERE SMOOTH AND NOT JAGGED. FOR SAMPLES THAT HAD DRAIN HOLES, ALL BREAKS TOOK PLACE ALONG AN ACTUAL HOLE. THIS WAS EXPECTED AS IT IS THE WEAKEST PART OF THE DRAIN. OUR DATA SHOWS THAT AN UNALTERED OR UNDAMAGED DRAIN SHOULD NOT BREAK WITH A FORCE OF LESS THAN 18 POUNDS. IF A BREAKAGE OCCURS, IT IS MOST LIKELY GOING TO TAKE PLACE AT AN ACTUAL DRAIN HOLE. LIKEWISE, IF A BREAK OCCURS, THE PATTERN LEFT ON THE LOOSE ENDS WOULD BE A SMOOTH EDGE. IT WAS ALSO OBSERVED THAT ONE END OF THE BREAKAGE FOR THE SAMPLES WITHOUT HOLES WAS TAPERED AFTER THE SMOOTH EDGE. THIS SUGGESTS THAT THE DRAIN FIRST STRETCHES, THEN HAS A CLEAN BREAK. ANY OTHER PATTERN ON THE EDGES WOULD SUGGEST THAT A DRAIN MAY HAVE BEEN DAMAGED OR ALTERED IN SOME FORM. WE WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS INCIDENT BUT BELIEVE THE BREAK WAS THE RESULT OF DAMAGE TO THE DRAIN WHICH COULD HAVE BEEN CAUSED BY A SUTURE OR INSTRUMENT, PRIMARILY DUE TO THE JAGGED/ROUGH EDGE OF THE BREAK, WHICH WAS NOT LOCATED AT A DRAIN HOLE, WHERE A BREAK WOULD BE EXPECTED.

    Description of Event or Problem · 1

    PT HAD BILATERAL TOTAL KNEE REPLACEMENT. ON POST OP DAY TWO, A SURGEON ATTEMPTED TO REMOVE THE DRAINS. ONE WAS REMOVED WITHOUT DIFFICULTY. RESISTANCE WAS MET ON THE SECOND DRAIN. THE PRIMARY SURGEON CAME IN THE NEXT DAY TO REMOVE IT. IT WAS REPORTED THAT RESISTANCE WAS MET AND THAT IT WAS PULLED ON AGGRESSIVELY UNTIL IT CAME OUT. WHEN IT WAS REMOVED, A PORTION REMAINED IN THE PT'S KNEE. THE RETAINED PIECE WAS SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 400CC EVACUATION W/ 10FR, 1/8" DRAIN, WOUND GCY MEDLINE INDUSTRIES, INC. DYNJWE402 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention