BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAT SILICONE DRAIN

    MDR report key: 3142897 · Received May 22, 2013

    Report

    Report Number
    1417592-2013-00043
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 4, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SILICONE DRAIN BROKE AS IT WAS BEING REMOVED. THE RETAINED PIECE WAS RETRIEVED WITH A FORCEPS AND NO FURTHER INTERVENTION WAS NECESSARY. THE DRAIN HAD PREVIOUSLY BEEN PLACED DURING AN ABDOMINAL SURGICAL PROCEDURE. THE FACILITY REPORTED THAT THE DRAIN HAD BEEN SECURED WITH SUTURES. IT IS NOT KNOWN IF ANY INSTRUMENTS WERE USED WHEN PLACING THE DRAIN. THE PIECE OF THE DRAIN THAT WAS EXTERNAL TO THE PT WAS RETURNED FOR EVAL. THE PIECE THAT WAS INITIALLY RETAINED WAS NOT RETURNED TO US. THE LENGTH OF THE RETAINED PIECE WAS NOT REPORTED AND COULD NOT BE ACCURATELY DETERMINED FROM THE RETURNED SAMPLE. THE FRACTURED END OF THE DRAIN WAS JAGGED IN APPEARANCE AND HAD TWO SEPARATE PIECES OF SUTURING MATERIAL THAT WERE WRAPPED AROUND THE TUBING APPROX 4 INCHES FROM THE FRACTURED END. THE JAGGED EDGES OF THE FRACTURED END AND THE FACILITY'S REPORT THAT THE DRAIN WAS SUTURED IN PLACE SUGGEST THAT THE TUBING MAY HAVE BEEN DAMAGED BY A SUTURING NEEDLE. THIS DAMAGE WOULD HAVE COMPROMISED THE INTEGRITY OF THE TUBING AND WOULD HAVE BEEN A CONTRIBUTING FACTOR TO THE REPORTED INCIDENT. WHEN DRAINS HAVE BEEN TESTED FOR TENSILE STRENGTH AND TORN ARTIFICIALLY, THE TEAR IS STRAIGHT AND NOT JAGGED. WE HAVE NO INFO TO SUGGEST A MANUFACTURING DEFECT CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. HOWEVER, DUE TO THE INCIDENT AND NEED FOR INTERVENTION, THIS MEDWATCH IS BEING FILED.

    Description of Event or Problem · 1

    THE DRAIN BROKE UPON REMOVAL. THE RETAINED PIECE WAS REMOVED WITH A FORCEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226368 FLAT SILICONE DRAIN GBX MEDLINE INDUSTRIES, INC. P1219461

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R