BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 2-LUMEN 4 FR X 13 CM

    MDR report key: 2102937 · Received May 4, 2011

    Report

    Report Number
    1036844-2011-00139
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 13, 2011
    Report Date
    May 3, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON AN 8 MONTH OLD FEMALE PT WITH PULMONARY SEPSIS IN THE PEDIATRIC INTENSIVE CARE UNIT. DURING PLACEMENT OF THE CATHETER, THEY EXPERIENCED DIFFICULTY WHEN REMOVING THE SPRING WIRE GUIDE (SWG). AS A RESULT, THE CATHETER AND SWG WERE REMOVED AS ONE. IT WAS OBSERVED THAT THE SWG BROKE AT THE LEVEL OF THE CURVATURE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011 FROM THE DISTRIBUTOR STATED THE SWG WAS REMOVED COMPLETELY ALONG WITH THE CATHETER FROM THE PT. A SECOND KIT WAS OPENED AND USED SUCCESSFULLY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 2-LUMEN 4 FR X 13 CM PEDIATRIC MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC RF0074493

    Patients

    Seq Age Sex Outcome Treatment
    1 8 MO