BEUDAMED
    FDA Adverse Event Other Summary report: N

    JP- 2189, JP - CHANNEL DRAIN 15FR, FULL FLUTE

    MDR report key: 806793 · Received January 10, 2007

    Report

    Report Number
    8030107-2007-00001
    Event Type
    Other
    Date Received
    January 10, 2007
    Date of Event
    November 30, 2006
    Report Date
    January 4, 2007
    Manufacturer
    DEGANIA SILICONE, LTD.
    Product Code
    GCY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    "THE DRAIN BROKE OFF IN THE PATIENT. THE DRAIN BROKE NOT UPON ATTEMPTED REMOVAL; IT JUST CAME APART WHERE WHITE MEETS CLEAR." THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT THE INCIDENT DESCRIPTION IS SIMILAR TO CARDINAL PQR 2006-10081 (DEGANIA SILICONE REF. # 879). ACCORDING TO THE REPORT, THE DRAIN BROKE AT THE SAME LOCATION WHERE IT BREAKS WHEN WE PULL TEST IT. THERE IS A HUB CONNECTING THE WHITE DRAIN WITH THE CLEAR TUBE. THE HUB IS GLUED TO BOTH THE DRAIN AND THE TUBE. THE MINIMUM PULL TEST SPECIFICATION IS 40N COMPARED TO 20N REQUIRED BY INTERNATIONAL STANDARD EN 1617. THE TEST RESULTS OF THE SAME LOT WERE: LOT NUMBER: P05051621, AVERAGE (N): 74.5, MINIMUM (N): 51.8. OUR ANALYSIS IS THAT THE PULL STRENGTH IS SUFFICIENT ALTHOUGH THE CONTACT PERSON IN THE HOSPITAL SAID SHE TOOK AN UNUSED DRAIN AND PULLED ON IT, "GAVE IT A GOOD TUG" AND IT, TOO CAME APART BECAUSE A PULL FORCE OF 40N OR EVEN 80N IS COMMON FOR AN AVERAGE PERSON. EVEN THOUGH WE THINK THE CURRENT DESIGN IS SUFFICIENT, WE DECIDED TO MAKE THE FOLLOWING CHANGES IN ORDER TO STRENGTHEN THE CONNECTIONS TO MINIMUM 50N: INCREASE THE WALL THICKNESS OF THE HUB BY 0.125MM. IMPROVE THE METHOD OF GLUING THE HUB WITH THE DRAIN AND THE TUBE.

    Description of Event or Problem · 1

    DRAIN BROKE OFF IN THE PATIENT. ADDITIONAL SURGERY REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JP- 2189, JP - CHANNEL DRAIN 15FR, FULL FLUTE SURGERY DRAIN GCY DEGANIA SILICONE, LTD. JP-2189 P05051621

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention