BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY

    MDR report key: 2932799 · Received November 19, 2012

    Report

    Report Number
    1820334-2012-00530
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    October 26, 2012
    Report Date
    November 1, 2012
    Manufacturer
    COOK, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT- UNKNOWN AS NOT PROVIDED BY REPORTER. EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. LESS THAN OR EQUAL TO 10 DAYS AGO. PATIENT - ADDITIONAL HOSPITALIZATION AND ANTIBIOTICS IS NOT LABELED. DEVICE CODE- DEVICE BREAKAGE IS NOT LABELED. CORRECTED DATA FROM USER FACILITY REPORT: LOT NUMBER IS UNCONFIRMED TO BE ASSOCIATED WITH THIS CASE. AS OF (B)(4) 2012, NO PRODUCT HAS BEEN RETURNED. QUALITY CONTROL INSURES THAT THE ASSEMBLY WITH WITHSTAND SPECIFIED PRESSURE, PERFORMS TENSILE TEST ON SHAFTS, EXTENSION TUBES AND HUBS. MATERIAL MUST WITHSTAND SPECIFIED LBS FOR EACH BOND AND DISTAL SHAFT. FINAL INSPECTION FOR TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER CONFIRMS CORRECT EXTENSION TUBE WITH WINGED FLLA AND THAT THEY ARE SECURELY ATTACHED, STAMPING ON WINGED FLLA AND EXTENSIONS MUST BE CORRECT AND LEGIBLE, AND CONFIRMS CORRECT CLAMP HAS BEEN USED. INSTRUCTIONS FOR USE (IFU) STATES PRECAUTIONS REGARDING TO IMPEDED LUMEN FLOW AND POWER INJECTION. WE ARE INCONCLUSIVE ON HOW THE DEVICE COULD HAVE CONTRIBUTED TO THE FAILURE MODE. COOK SUPPLIER HAS BEEN CONTACTED DUE TO PRIOR SIMILAR COMPLAINTS. THEY COULD NOT RE-CREATE THE FAILURE MODE. WE ARE INCONCLUSIVE AS TO WHY THE FAILURE MODE HAPPENED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    PER MEDWATCH FORM: THERE HAVE BEEN FIVE INSTANCES (1820334-2012-00496, 1820334-2012-00525, 1820334-2012-00526, 1820334-2012-00527, AND 1820334-2012-00532) OF THIS EVENT AND AT LEAST THREE PATIENTS INVOLVED. PT REQUIRED LINE REPLACEMENT AND HOSPITALIZATION FOR 5 DAYS WITH IV ANTIBIOTICS DUE TO POSITIVE BLOOD CULTURE AT TIME OF BREAK. DISCHARGED HOME WITH NEW PICC LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK, INC. NA 3500791

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention