BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL LINE KIT

    MDR report key: 3982819 · Received July 2, 2014

    Report

    Report Number
    1036844-2014-00291
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURES ARE BEING PERFORMED IN THE INTENSIVE CARE UNIT. DURING CATHETER INSERTIONS, TWO PHYSICIANS HAVE COMPLAINED THAT THE SPRING WIRE GUIDES ARE BENDING EASILY AND KINKING AND THEY ARE UNABLE TO ADVANCE. THEY ARE HAVING TO OPEN SEVERAL KITS IN ORDER TO SUCCESSFULLY PLACE THE ARTERIAL LINE. THEY DO NOT KNOW IF THIS CAUSED ANY DELAYS IN TREATMENT AND THERE HAVE BEEN NO PATIENT DEATHS OR COMPLICATIONS REPORTED. THEY DO NOT KNOW HOW MANY TIMES THIS HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387555 ARTERIAL LINE KIT ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC. 23F14C0827

    Patients

    Seq Age Sex Outcome Treatment
    1