BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER

    MDR report key: 969883 · Received December 27, 2007

    Report

    Report Number
    1820334-2007-00518
    Event Type
    Injury
    Date Received
    December 27, 2007
    Date of Event
    November 2, 2007
    Report Date
    November 30, 2007
    Manufacturer
    COOK INCORPORATED
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PRODUCT WAS RETURNED TO ASSIST IN OUR INVESTIGATION. UNFORTUNATELY, BASED ON THE INFORMATION PROVIDED, WE ARE UNABLE TO DETERMINE HOW THE WIRE BECAME SEPARATED AND LEFT IN THE PATIENT. PER OUR ATTACHED INSTRUCTION FOR USE BOOKLET, IT IS STATED: "USE OF ECG AND/OR FLUOROSCOPY ARE SUGGESTED FOR ACCURATE CATHETER PLACEMENT." BASED ON THE INFORMATION PROVIDED, IT IS FEASIBLE TO SUGGEST THIS INCIDENT OCCURRED DUE TO USER ERROR.

    Description of Event or Problem · 1

    THE INCIDENT INVOLVED A CHILD WHO HAD THE PICV INSERTED INTO THE RIGHT ARM BY THE ANESTHETIST DURING SURGERY IN 2007. FOLLOWING INSERTION, THE ANESTHETIST REPORTED THAT THE PICV WAS FLUSHED AND WORKING. POST THEATRE, THE WARD STAFF REPORTED THE PICV TO BE PROBLEMATIC AND THE ANESTHETIST ATTENDED THE PATIENT ON THE NEXT DAY, AND THE PICV WAS REMOVED. A FEW DAYS LATER, ANOTHER PICV WAS INSERTED IN THE LEFT ARM IN THE RADIOLOGY DEPT (QDI). THE CHILD WAS DISCHARGED A WEEK LATER. POST DISCHARGE ON TWO DAYS LATER, THE CHILD'S PARENTS REVIEWED THE X-RAYS AND NOTED THAT THE CHILD APPEARED TO HAVE WIRES IN BOTH ARMS. THE PATIENT WAS PRESENTED TO THE EMERGENCY DEPARTMENT THE SAME DAY, AND ULTRASOUND AND CHEST X-RAYS WERE CARRIED CUT. THE REPORT STATED "THERE IS A FOREIGN BODY IN THE RIGHT ARM AND THIS IS IN KEEPING WITH A WIRE FROM A PICC INTRODUCTION." THE RETAINED WIRE WAS SUCCESSFULLY REMOVED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER DQO - CENTRAL VENOUS CATHETER DQO COOK INCORPORATED NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention