BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILICON WOUND DRAIN

    MDR report key: 2501291 · Received March 16, 2012

    Report

    Report Number
    1018233-2012-00265
    Event Type
    Injury
    Date Received
    March 16, 2012
    Date of Event
    January 22, 2012
    Report Date
    February 28, 2012
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING PRECAUTIONS TO AVOID THE POSSIBILITY OF DRAIN DAMAGE OR BREAKAGE: AVOID SUTURING THROUGH DRAINS. DRAINS 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. DRAINS SHOULD BE CHECKED FOR FREE MOTION DURING CLOSURE TO MINIMIZE THE POSSIBILITY OF BREAKAGE. DRAIN REMOVAL SHOULD BE DONE GENTLY BY HAND. DRAINS 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. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH REPORT (B)(4) THAT WHILE REMOVING A WOUND DRAIN FROM A PATIENT IN THE ICU ON (B)(6) 2012, THE DRAIN BROKE REMAINING IN THE PATIENT. A CT WAS PERFORMED AND IT WAS SUSPECTED THAT THE DRAIN WAS STITCHED TO THE FACIA. THE PATIENT WAS RETURNED TO THE OPERATING ROOM AND THE RETAINED PORTION OF THE DRAIN WAS REMOVED. THERE WAS SOME RESISTANCE BUT NO MORE THAN USUAL. IT TORE AS SOON AS PRESSURE WAS APPLIED. UPON EXAMINATION OF THE RETAINED PORTION, IT WAS EVIDENT THAT WHILE SECURING THE DRAIN WHEN IT WAS INSERTED AFTER OPEN HEART SURGERY, A SUTURE PENETRATED THE DRAIN. THE TORN END OF THE DRAIN WAS IRREGULAR IN SHAPE WHERE IT SEPARATED FROM THE EXTERNAL PORTION OF THE DRAIN. THE PATIENT RETURNED TO THE INTENSIVE CARE UNIT TO CONTINUE RECOVERY FROM THE ORIGINAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILICON WOUND DRAIN GBX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention