BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUBLESS SILICONE FLAT DRAIN

    MDR report key: 2000978 · Received February 18, 2011

    Report

    Report Number
    1018233-2011-00017
    Event Type
    Injury
    Date Received
    February 18, 2011
    Report Date
    January 20, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RETURNED FOR EVALUATION FINDING THE FLAT DRAIN TUBE BROKEN AT THE FIRST EYE AT THE BEGINNING OF THE TRANSITION. THE SAMPLE WAS EXAMINED UNDER MAGNIFICATION FINDING NO EVIDENCE OF ANY PUNCTURES. THE BROKEN SURFACE HAD JAGGED EDGES WHICH IS INDICATIVE OF EXCESSIVE FORCE HAVING BEEN APPLIED TO THE DRAIN BEYOND ITS TENSILE CAPABILITIES. THERE IS NOTHING IN THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED FAILURE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS A LOT NUMBER WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING PRECAUTIONS "ADDITIONAL PERFORATIONS SHOULD NOT BE MADE IN THE DRAIN. 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." AN ADDITIONAL WARNING STATES: "DRAIN BREAKAGE MAY REQUIRE SURGICAL REMOVAL." (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DRAIN BROKE OFF IN THE PATIENT. THE NURSE REPORTED NOTHING UNUSUAL DURING THE DRAIN REMOVAL UNTIL AFTER IT WAS NOTICED THAT THE DRAIN PIECE WAS MISSING. PATIENT WAS SENT TO SURGERY FOR REMOVAL OF THE INDWELLING PORTION. THE PATIENT WAS REPORTED TO BE DOING WELL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention