BEUDAMED
    FDA Adverse Event Other Summary report: N

    SAHARA

    MDR report key: 411217 · Received August 19, 2002

    Report

    Report Number
    1221601-2002-00016
    Event Type
    Other
    Date Received
    August 19, 2002
    Report Date
    August 19, 2002
    Manufacturer
    GENZYME BIOSURGERY A DIV OF GER
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED THAT THERE HAD BEEN AN INADVERTENT CLAMPING OF THE PT CHEST TUBE WITH THE BLUE CLAMP CONTAINED ON THE DRAIN. THE PT OUTCOME WAS A PNEUMOTHORAX. THE CUSTOMER BELIEVES IT OCCURRED DURING TRANSPORT AND THAT IT WAS AN UNINTENTIONAL CLAMPING BY AN EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAHARA FLUID MANAGEMENT KDQ GENZYME BIOSURGERY A DIV OF GER S-1100B *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention