BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE KIT

    MDR report key: 2483504 · Received March 5, 2012

    Report

    Report Number
    1036844-2012-00068
    Event Type
    Injury
    Date Received
    March 5, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 5, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    GBX
    PMA / PMN Number
    K895516
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEW PHYSICIANS IN THE MICU AND THE ER HAVE HAD ISSUES WHEN USING THESE CATHETERS. WHEN THEY LOAD THE DILATOR/TROCAR PART INTO THE CATHETER, IT DOES NOT GO ALL THE WAY TO THE END OF THE CATHETER LEAVING A FLEXIBLE END. WHEN ATTEMPTING TO PASS THE GUIDE WIRE THROUGH THE TIP, IT GETS CAUGHT AND THEY ARE UNABLE TO ADVANCE. IF THEY FORCE THE DILATOR/TROCAR SET MORE INTO THE CATHETER TO ENSURE IT REACHES THE TIP, IT THEN GETS STUCK IN THE CATHETER AND IS DIFFICULT TO REMOVE. IT WAS STATED THIS WAS NOTICED AT LEAST SIX TIMES. THE PHYSICIAN STATED THAT FOR THE SIX ADD'L TIMES THIS OCCURRED, HE WAS ABLE TO, IN SOME CASES, PLACE THE CATHETER AND IN SOME CASES, HE HAD TO REMOVE EVERYTHING AND A SURGICAL CHEST TUBE HAD TO BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DRAINAGE KIT CAVITY DRAINAGE CATHETER PRODUCTS GBX ARROW INTL., INC. RF1071758

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention CHEST TUBE