BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELDINGER CENTRAL VENOUS CATHETER

    MDR report key: 323447 · Received March 28, 2001

    Report

    Report Number
    8020616-2001-00004
    Event Type
    Other
    Date Received
    March 28, 2001
    Date of Event
    January 24, 2001
    Report Date
    February 28, 2001
    Manufacturer
    BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD.
    Product Code
    DQO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURATION OF USAGE FOR THE CASE REPORTED: INTENDED ICU ON 1/19/2001 CATHETER PLACEMENT ON THE SAME DAY, THROMBUS WAS IDENTIFIED ON 1/29/2001 STARTED WITH HIGH DOSE HEPARIN AND DIED ON 2/10/2001 OF CARDIAC/CIRCULAR FAILURE. NO REPLACEMENT. THE CATHETER WAS NOT IN USE FOR MORE THAN 30 DAYS.

    Description of Event or Problem · 1

    CASE WAS PROLONGED ICU WITH PROLONGED VENTILATION AND FEEDING. CENTRAL VENOUS CATHETER WAS PLACED ON ADMISSION TO ICU. THE PATIENT, WHO'S UNDERLYING CONDITION WAS NOT SPECIFIED. DATE OF BIRTH NOT SPECIFIED. ADMITTED TO ICU NOT SPECIFIED. CURRENTLY REMAINS IN ICU ON VENTILATION. CATHETER PLACEMENT WAS VIA RIGHT-SIDED SUBCLAVIAN VENA PUNCTURE. CATHETER IS USED FOR "CVP" AND PARENTERAL NUTRITION. SYMPTOMS WERE FIRST IDENTIFIED AFTER APPROXIMATELY 10 DAYS, WHICH CONSISTED OF SWELLING OF THE RIGHT ARM. AN ECHO-GRAM OF THE IN-SITU CATHETER WAS TAKEN. THIS IDENTIFIED THROMBUS FORMATIONS ON THE EXTERNAL SURFACE OF THE CATHETER WITHIN THE VENA SUBCLAVIA. TO MANAGE THE THROMBOSIS, HEPARIN IS FLUSHED THROUGH THE LINE DAILY AND THE PATIENT GIVEN HIGH DOSE SUBCUTANEOUS INFUSIONS. THE CATHETER CURRENTLY IN-SITU IS A 7FR TRIPLE LUMEN X 150CM CATALOGUE NUMBER 681133. ITS LOT NUMBER WAS NOT AVAILABLE, BUT THE CURRENT LOT IN ICU STOCK IS LOT 001065. THE PATIENT, CURRENTLY STILL ON VENTILATION, AND CONFIRMED THAT THE RIGHT ARM AND HAND WERE SIGNIFICANTLY SWOLLEN. IT IS NORMAL PRACTICE OF THE HOSPITAL FOR NURSES TO EXPLANT CVC'S, HOWEVER, THE ANAESTHETIST HAS AGREED, WHEN APPROPRIATE, TO EXPLANT THE CATHETER FROM THE PATIENT CURRENTLY IN ICU AND MAKE IT AVAILABLE TO BD FOR EXAMINATION. ADDITIONAL INFORMATION RECEIVED STATED THAT PATIENT DIED AND THE NURSING STAFF REMOVED THE CATHETER. DESPITE THE HOSPITAL KEENNESS TO MAKE IT AVAILABLE FOR EXAMINATION, THE HOSPITAL REPORTED THAT THEY DESTROYED IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13618 SELDINGER CENTRAL VENOUS CATHETER CENTRAL VENOUS CATHETER DQO BECTON DICKINSON CRITICAL CARE SYSTEMS PTE LTD. HYDROCATH 3 LUMEN X 150 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention