BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER KIT

    MDR report key: 297934 · Received September 28, 2000

    Report

    Report Number
    1056436-2000-00195
    Event Type
    Injury
    Date Received
    September 28, 2000
    Date of Event
    September 1, 2000
    Report Date
    September 12, 2000
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 9/01/2000, THE FACILITY'S HEAD NURSE INFORMED THE MFR'S (MFR.) REPRESENTATIVE OF THE FOLLOWING: THE DEVICE WAS BEING EXPLANTED AND DURING THE PROCEDURE, THE CATHTER SNAPPED/BROKE. WHEN ASKED IF THE DEVICE IN QUESTION WAS AVAILABLE TO BE RETURNED TO THE MFR. FOR ANALYSIS, SHE STATED THAT THE DEVICE WAS SENT TO THE FACILITY'S BIO-ENGINEERING DEPT FOR EVAL. THE DEVICE WOULD BE AVAILABLE WHEN THEY WERE THROUGH WITH IT. SHE REQUESTED THAT THE MFR'S PRODUCT MANAGER CONTACT HER. ON 09/08/2000, THE MFR'S PRODUCT MANAGER DISCUSSED THE EXPERIENCE WITH THE FACILITY'S HEAD NURSE. IT WAS STATED THAT THE FACILITY'S STANDARD PROCEDURE FOR REMOVING A CENTRAL LINE IS TO PULL IT OUT WITHOUT ANY BLUNT DISSECTION. THE MFR'S PRODUCT MANAGER INFORMED HER THAT DUE TO THE FIBROUS NATURE OF THE PRODUCTS' CUFF, THE TISSUE IN-GROWTH WITH THE CATHETER WOULD BE MORE SEVERE THAN ANY WITH OTHER CENTRAL LINE. THIS CUFF AND THE TISSUE IN-GROWTH PREVENTS THEM FROM BEING ABLE TO PULL THE CATHETER WITHOUT BLUNT DISSECTION. THE HEAD NURSE REQUESTED IN WRITING A RECOMMENDED PROCEDURE FOR REMOVING THE CUFF AND EXPLANTING THE CATHETER. THE MFR'S PRODUCT MANAGER FAXED THE FACILITY'S HEAD NURSE THE MFR'S INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT AND REFERRED HER TO THE SECTION REMOVING A CENTRAL VENOUS CATHETER THAT STATES-TO REMOVE THE CATHETER, FREE THE CUFF FROM THE TISSUE AND PULL THE CATHETER GENTLY AND SMOOTHLY. DO NOT USE A SHARP JERKING MOTION OR UNDUE FORCE. WARNING: IF THE CATHETER OFFERS RESISTANCE, DO NOT PULL FURTHER. PERFORM A CUTDOWN AND REMOVE ALL SUTURES AT THE VENOTOMY SITE. ON 09/07/2000, THE DISTRIBUTOR'S SALES REPRESENTATIVE INFORMED THE MFR'S REPRESNTATIVE THAT PER THE FACILITY'S HEAD NURSE, THE DEVICE IN QUESTION WOULD NOT BE RETURNRED TO THE MFR FOR ANALYSIS. ON 09/28/2000, THE MFR RECEIVED MEDWATCH REPORT #0000260105-2000-0005. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHERES-FLOW CENTRAL VENOUS CATHETER KIT CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA SE00125

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention