BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GBX CATHETER, IRRIGATION

    MDR report key: 5476079 · Received March 3, 2016

    Report

    Report Number
    1820334-2016-00063
    Event Type
    Injury
    Date Received
    March 3, 2016
    Report Date
    March 3, 2016
    Manufacturer
    COOK INC.
    Product Code
    GBX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RESUBMITTED AS THE PREVIOUS REPORT SUBMITTED ASSOCIATED WITH MDR # 1820334-2016-00063 ON 03MAR2016 WAS INADVERTENTLY SUBMITTED AS A FOLLOW UP REPORT INSTEAD OF AN INITIAL REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED OR FURTHER INVESTIGATION WAS CONDUCTED. AGE: INFORMATION NOT PROVIDED BY THE REPORTER. WEIGHT: INFORMATION NOT PROVIDED BY THE REPORTER. PATIENT CODE: ADDITIONAL PROCEDURE IS NOT LABELED. DEVICE CODE: HUB/MATERIAL SEPARATION IS NOT LABELED.

    Description of Event or Problem · 1

    THE INITIAL INFORMATION PROVIDED STATED THAT THE END OF THE CATHETER SEPARATED, NO DETAILS PROVIDED. HOWEVER, PER THE ADDITIONAL INFORMATION PROVIDED ON MW5059360 RECEIVED BY THE MANUFACTURER ON 12FEB2016: THE PATIENT WAS IN THE BATHROOM WHEN THE CHEST TUBE DISLODGED. THE CHEST TUBE WAS FOUND TO BE BROKEN OFF AT THE HUB, WHERE THE TWO SECTIONS OF TUBING MEET AND ARE ATTACHED TOGETHER. THE PATIENT RETURNED TO INTERVENTIONAL RADIOLOGY, WHERE THE CHEST TUBE WAS REPLACED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135416 GBX CATHETER, IRRIGATION GBX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown