BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANSONNENBERG CHEST DRAIN SET

    MDR report key: 1646841 · Received March 31, 2010

    Report

    Report Number
    2134265-2010-01412
    Event Type
    Injury
    Date Received
    March 31, 2010
    Date of Event
    December 26, 2009
    Report Date
    March 2, 2010
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GBX
    PMA / PMN Number
    K925176
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTING THAT FOLLOWING PLACEMENT OF A CHEST DRAINAGE CATHETER, THE CATHETER BROKE INSIDE THE PATIENT. THE PATIENT HAD A 14F VANSONNENBERG PIGTAIL DRAINAGE CATHETER PLACED IN THE RIGHT PLEURAL CAVITY. WHILE MOVING THE PATIENT, THE CHEST TUBE WAS PULLED OUT AND LATER REVEALED IT HAD BEEN BROKEN AND THAT PART OF THE DEVICE REMAINED INSIDE THE PATIENT. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL FOR TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANSONNENBERG CHEST DRAIN SET CATHETER, IRRIGATION GBX BOSTON SCIENTIFIC - SPENCER M001205120

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention