BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRAINAGE KIT

    MDR report key: 2476564 · Received March 1, 2012

    Report

    Report Number
    1036844-2012-00055
    Event Type
    Injury
    Date Received
    March 1, 2012
    Date of Event
    February 16, 2012
    Report Date
    March 1, 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 THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT IN THE ER. WHEN THEY LOADED THE DILATOR/TROCAR PART INTO THE CATHETER IT DID 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 WERE 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. AS A RESULT, EVERYTHING WAS REMOVED AND A SURGICAL CHEST TUBE HAD TO BE USED. THERE WAS A 2 TO 3 HOUR DELAY IN TREATMENT, NO PT DEATH, AND NO PT COMPLICATIONS WERE REPORTED. THE PT STAYED IN THE HOSP A FEW DAYS AND WAS THEN DISCHARGED.

    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