BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA CATH KIT: 20 GA X 1-3/4IN

    MDR report key: 3101406 · Received May 3, 2013

    Report

    Report Number
    1036844-2013-00166
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 3, 2013
    Report Date
    May 1, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE 4T NURSING UNIT OF THE BURN CENTER, THE ARTERIAL LINE BROKE OFF DURING REMOVAL. THE PIECE OF THE ARTERIAL LINE THAT BROKE OFF RETAINED IN THE PATIENT. INTERVENTIONAL RADIOLOGY DECIDED TO LEAVE THE FRAGMENT IN PLACE SINCE IT WAS CONFIRMED THE PATIENT HAD ADEQUATE COLLATERAL CIRCULATION SO FLOW WAS NOT COMPROMISED TO THE PATIENT'S HAND. THERE WAS NO ATTEMPT AT ANOTHER PROCEDURE. IT IS UNKNOWN IF THERE WAS A DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195015 RA CATH KIT: 20 GA X 1-3/4IN ARTERIAL CATHETER PRODUCTS DQX ARROW INTL., INC. RF2095172

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK