BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CATH SET: 20 GA X 3-1/16"

    MDR report key: 4212800 · Received August 4, 2014

    Report

    Report Number
    9680794-2014-00138
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 12, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ANAESTHETIST-RESUSCITATOR INSERTED THE CATHETER INTO THE HUMERAL (BRACHIAL) ARTERY OF THE PATIENT. AFTER THE CONNECTION, THE MONITOR READ A VERY GOOD REFLUX WITH A BP WAVEFORM THAT WAS COMPREHENSIBLE. HOWEVER THE WAVEFORM DISAPPEARED AFTER 2 MINUTES OF USE, DESPITE THE FACT THAT THE PRESSURE POUCH DID NOT DEFLATE. THE ANAESTHETIST-RESUSCITATOR THEN NOTICED A REFLUX IN THE TRANSFUSION LINE OF MORE THAN 5 CM; ALSO THERE WAS A RESISTANCE IN THE PURGING EVEN THOUGH THE SUCTION WAS WORKING PERFECTLY. HE EVENTUALLY MANAGED TO PURGE THE CATHETER. THE CATHETER WORKED PROPERLY THROUGH THE BP MONITORING AND THE BLOOD SAMPLE TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455427 ARTERIAL CATH SET: 20 GA X 3-1/16" ARTERIAL CATHETER PRODUCTS DQX ARROW INTERNATIONAL INC. 14F14D0112

    Patients

    Seq Age Sex Outcome Treatment
    1