BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CATH SET: 20GA X 5CM

    MDR report key: 3193107 · Received June 25, 2013

    Report

    Report Number
    3006425876-2013-00116
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 4, 2013
    Report Date
    June 25, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE INTENSIVE CARE DEPARTMENT, AFTER INTRODUCTION OF THE CATHETER, THE CATHETER KINKED. THE CATHETER WAS INSERTED IN THE RADIAL ARTERY, OF AN 83 YEAR OLD FEMALE PATIENT. NO BLOOD PRESSURE MONITORING OR BLOOD SAMPLING WERE POSSIBLE DUE TO THE CATHETER KINKING. THE CATHETER WAS REMOVED. AS A RESULT, A NEW KIT WAS OPENED AND USED SUCCESSFULLY. THERE WAS A DELAY IN TREATMENT, BUT NO HARM WAS CAUSED TO THE PATIENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288494 ARTERIAL CATH SET: 20GA X 5CM ARTERIAL CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. ZF2124328

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR