BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 3-LUMEN 7FR X 16CM

    MDR report key: 2092850 · Received May 11, 2011

    Report

    Report Number
    3006425876-2011-00031
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 20, 2011
    Report Date
    May 9, 2011
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REMOVAL OF THE SPRING WIRE GUIDE (SWG), IT WAS DISTENDED AND IT TOOK AWAY THE CATHETER WITH IT. THERE WAS NO PT DEATH. ADDITIONAL INFO RECEIVED ON (B)(6)2011 FROM THE TELEFLEX (B)(4) OFFICE STATED THE CATHETER WAS INSERTED VIA THE PT'S RIGHT SUBCLAVIAN. DURING THE REMOVAL OF THE SWG, RESISTANCE WAS MET. THE MD REMOVED THE SWG AND THE CATHETER AS ONE UNIT. THE SWG APPEARED UNRAVELED. THE MD DID INSERT ANOTHER SWG INTO THE SAME INSERTION SITE AND USED THE SAME CATHETER TO COMPLETE THE INSERTION. THERE WAS NO REPORTED PT DEATH. THE PT WAS INJURED AND MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS NO DELAY IN THERAPY. THE PT COMPLICATION WAS PNEUMOTHORAX. THE PT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 16CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL, INC. ZF0033559

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other