BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER TRAY

    MDR report key: 2840501 · Received November 13, 2012

    Report

    Report Number
    1820334-2012-00496
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    July 2, 2012
    Report Date
    October 24, 2012
    Manufacturer
    COOK INC
    Product Code
    LJS
    PMA / PMN Number
    K072625
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVAL: PER THE CUSTOMER, NO PRODUCT WILL BE RETURNED. QUALITY CONTROL INSURES THAT THE ASSEMBLY WILL 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. CONFIRM CORRECT CLAMP HAS BEEN USED. INSTRUCTIONS FOR USE (IFU) STATES PRECAUTIONS REGARDING TO IMPEDED LUMEN FLOW AND POWER INJECTION. INCONCLUSIVE ON HOW THE DEVICE COULD HAVE CONTRIBUTED TO THE FAILURE MODE. OUR SUPPLIER HAS BEEN CONTACTED DUE TO PRIOR SIMILAR COMPLAINTS. THEY COULD NOT RECREATE THE FAILURE MODE. IT IS 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, 00525, 00526, 00527, AND 00532) OF THIS EVENT AND AT LEAST THREE PTS INVOLVED. FOUR FRENCH DUAL LUMEN PICCS ARE BREAKING AT THE WHITE HUB W/O ANY OBVIOUS REASON. THE CATHETER APPEARS TO BE PULLING OUT OF THE HUB AND THREE OF THESE BREAKS OCCURRED WHEN THE LINE WAS NOT IN USE. THE FIVE INSTANCES OF THIS TYPE OF EVENT HAD THE DEVICE PLACE FOR 18 DAYS, 21 DAYS, 42 DAYS, 24 DAYS, AND 18 DAYS WHEN THE BREAKS OCCURRED. ALL IN PEDIATRIC PTS. ONE PT IS NON AMBULATORY, ONE PT WAS NON AMBULATORY IN ICU FOR THE MAJORITY OF THE TIME THE LINES WERE IN PLACE, THE OTHER WAS NON AMBULATORY IN ICU FOR THE ENTIRE TIME THE LINES WERE IN PLACE. NO REPORTED ISSUES WITH TUBING OR LINES BEING PULLED/CAUGHT. FOR ALL CASES, THE PERSON WHO INSERTED THE LINE WAS TRAINED AND CERTIFIED IN THE PROCEDURE (AN INTERVENTIONAL RADIOLOGIST). ALL OF THE PICCS WERE SUTURED IN PLACE AND COVERED WITH A DRESSING. THE LINES WERE SUTURED IN PLACE AND COVERED WITH A DRESSING. THE LINES ARE FLUSHED WITH A 10 ML-SIZED SYRINGE. THE LINES ARE FLUSHED MINIMUM 3-5 ML. THESE DEVICES ARE STORED ON CARTS IN A SUPPLY ROOM. THE CATHETERS ARE IN OPAQUE PACKAGING (STERILE INSERTION TRAY). IN ONE PT, THE LINE WAS REMOVED AND PT COMPLETED TREATMENT WITH PERIPHERAL VASCULAR ACCESS AND REPEATED VENIPUNCTURES FOR LABS. ONE PT REQUIRES ONGOING, CONTINUOUS INFUSION OF VASOACTIVE MEDICATIONS AND SO HAS HAD TO UNDERGO LINE REPLACEMENT 3 TIMES. ADDITIONALLY, ONE INCIDENT NECESSITATED HOSPITAL ADMISSION D/T FEVER AND POSITIVE BLOOD CULTURE. PT WAS TREATED WITH ANTIBIOTICS INPATIENT FOR 5 DAYS. ONE PT WAS CRITICALLY ILL THROUGHOUT AND REQUIRED REPLACEMENT OF THE LINE TWICE. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention