BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD SILICONE CHANNEL DRAING

    MDR report key: 2230700 · Received August 17, 2011

    Report

    Report Number
    1018233-2011-00195
    Event Type
    Injury
    Date Received
    August 17, 2011
    Report Date
    July 26, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS NOT RETURNED TO BARD FOR EVAL. THE LOT NUMBER OF THE INCIDENT DEVICE WAS NOT PROVIDED BY THE USER FACILITY. HOWEVER, WE HAVE REVIEWED THE DEVICE HISTORY RECORDS FOR LOT NUMBERS PROVIDED IN THE SHIPPING RECORDS FOR THIS FACILITY FROM JAN 2011 - JULY 2011 AND DID NOT FIND ANYTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS A FINISHED GOOD, QA PERFORMS RANDOM VISUAL INSPECTIONS FOR DAMAGED COMPONENTS PRIOR TO PRODUCT RELEASE. IN ADDITION, THIS PRODUCT CODE IS RECEIVED FROM AN EXTERNAL SUPPLIER WHO CERTIFIES THAT THE PRODUCT HAS BEEN MFG ACCORDING TO BARD SPECS. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING WARNING: "WHEN PLACING DRAIN(S) CARE SHOULD BE TAKEN TO ENSURE THAT THE CHANNELED PORTION OF THE WOUND DRAIN LIES COMPLETELY WITHIN THE CONFINES OF THE WOUND." IT ALSO STATES, "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. SURGICAL REMOVAL MAY BE NECESSARY IF DRAIN IS DIFFICULT TO REMOVE OR BREAKS." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE DAY POST-OP FROM A SPINAL PROCEDURE, IT WAS NOTICED THAT THERE WAS NO OUTPUT FROM THE DRAIN. WHEN THE DRAIN WAS PULLED, THEY DISCOVERED THE PT HAD DEVELOPED A HEMATOMA. THE PT WAS TAKEN TO SURGERY TO DRAIN THE HEMATOMA. THE FACILITY STATED THAT THE DRAINS ARE COLLAPSING WHILE IN USE. THE PT HAS BEEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD SILICONE CHANNEL DRAING GBX C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention