BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2

    MDR report key: 1063461 · Received June 20, 2008

    Report

    Report Number
    1036844-2008-00098
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    May 14, 2008
    Report Date
    June 20, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    K071538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER, THAT IN 2006, THE MD PLACED THE CENTRAL VENOUS CATHETER INTO A MALE PT, IN THE INTENSIVE CARE UNIT. WHEN THE PROCEDURE WAS COMPLETED, THE MD NOTED PRIOR TO CLOSURE THAT THE SPRING WIRE GUIDE (SWG) HAD BEEN RETAINED. THE CHEST X-RAY RESULT WAS POSITIVE THAT THE SWG RETAINED IN THE RIGHT SUBCLAVIAN, SPECIAL PROCEDURE NEGATIVE FOR PNEUMOTHORAX. MEDICAL HISTORY INCLUDES CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC RESPIRATORY FAILURE ON VENT, HYPOTHYROIDISM, HYPOADRENALISM, S/P PEG PLACEMENT. THE SALES REP MADE A SITE VISIT AND SPOKE WITH THE CLINICIAN. THE PT LATER DID EXPIRE; HOWEVER, IT WAS STATED TO THE SALES REP IT WAS NOT DUE TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8IN (2 ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTL., INC. RL7126250

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death