BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA CATH SET: 22 GAX 1-3/4 IN (4.45 CM)

    MDR report key: 3140021 · Received May 29, 2013

    Report

    Report Number
    1036844-2013-00185
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 10, 2013
    Report Date
    May 28, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MD WAS ATTEMPTING TO PLACE THE ARTERIAL LINE AND THE CATHETER WAS NOT FUNCTIONING PROPERLY. THE CATHETER WAS UNABLE TO ADVANCE AND THE WIRE WOULD NOT PASS. ONCE THE CATHETER WAS REMOVED, THE MD NOTED THAT IT WAS CRACKED. THE CATHETER WAS NOT REPLACED. 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
    233844 RA CATH SET: 22 GAX 1-3/4 IN (4.45 CM) ARTERIAL CATHETER PRODUCTS DQO ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK