BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BECTON DICKSON

    MDR report key: 1013093 · Received March 12, 2008

    Report

    Report Number
    MW5005864
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    December 28, 2007
    Report Date
    March 6, 2008
    Manufacturer
    BECTON DICKINSON/INFUSION THERAPY SYSTEMS, INC
    Product Code
    KYZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO THE HOSP IN LATE 2007 WITH ABDOMINAL PAIN. A CT SCAN SHOWED A RETAINED FOREIGN BODY THAT WAS 3CM BY 1CM WITH A RING AROUND IT. THE PATIENT WAS TAKEN TO SURGERY ON THE NEXT DAY FOR REMOVAL OF THE FOREIGN BODY WHICH WAS IDENTIFIED AS THE PLASTIC CAP OF A CATHETER TIP SYRINGE (CALLED A TOOMEY SYRINGE BY STAFF). THIS SYRINGE WAS USED TO INJECT SEPRA FILM DURING A LAPAROSCOPIC CHOLECYSTECTOMY AND LYSIS OF ADHESIONS AROUND THE GALLBLADDER ON NINETEEN DAYS PRIOR TO ORIGINAL DATE. CONTRIBUTING FACTORS TO THE RETENTION OF THE SYRINGE CAP WERE IDENTIFIED DURING AN INVESTIGATION OF THIS OCCURRENCE. THOSE FACTORS ARE AS FOLLOWS: THE SYRINGE AND CAP ARE OF THE SAME COLOR AS WELL AS THE SEPRA FILM MIXED IN SALINE THAT THE SYRINGE CONTAINED AT THE TIME OF USE. THE LIGHTS IN THE OPERATING ROOM ARE DIMMED SECONDARY TO THE PROCEDURE BEING LAPAROSCOPIC. THE SURGEON WAS NOT AWARE THAT THE CAP WAS STILL ON THE SYRINGE WHEN HE INJECTED THE SEPRA FILM THROUGH ONE OF THE TROCAR SITES. THE CAP HAS TO STAY ON THE SYRINGE, SO NONE OF THE SOLUTION SPILLS OUT PREMATURELY. THE CAP OF THE SYRINGE IS BEING KEPT SECURED BY RISK MGMT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BECTON DICKSON CATHETER TIP SYRINGE (60ML) KYZ BECTON DICKINSON/INFUSION THERAPY SYSTEMS, INC UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention NO