BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC

    MDR report key: 6027197 · Received October 13, 2016

    Report

    Report Number
    1820334-2016-01202
    Event Type
    Malfunction
    Date Received
    October 13, 2016
    Date of Event
    September 14, 2016
    Report Date
    June 15, 2017
    Manufacturer
    COOK INC
    Product Code
    LJS
    PMA / PMN Number
    K041849
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, TRENDS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. AN EXAMINATION OF PHOTOGRAPHS REVEALED A LONGITUDINAL SPLIT IN THE LUMEN APPROXIMATELY 1 CM LONG THAT DOES NOT INVOLVE THE HUB OR MANIFOLD. THE ACTUAL DEVICE WAS RETURNED, VISUALLY EXAMINED AND FUNCTIONALLY TESTED. WATER WAS INJECTED INTO THE SYRINGE USING A SYRINGE; A LEAK WAS NOTED MID-WAY DOWN THE CATHETER. A 1.4 CM SPLIT WAS SEEN IN THE CATHETER MATERIAL 8 CM FROM THE PROXIMAL END USING A MAGNIFYING SCOPE. A DOCUMENT BASED INVESTIGATION EVALUATION WAS ALSO PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE COMPLAINT IS CONFIRMED BASED UPON THE INVESTIGATION OF THE DEVICE HOWEVER A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ALTHOUGH THE SPECIFIC RPN AND LOT WERE NOT PROVIDED, IT WAS REPORTED THAT A PICC PRODUCT, BEING USED FOR A (B)(6) STUDY, WAS FOUND TO BE COMPLETELY SPLIT AND LEAKING A WEEK POST INSERTION . THEREFORE, THE LINE WAS REPLACED ENTIRELY. PER INFORMATION PROVIDED BY THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678616 TURBO-JECT® DOUBLE LUMEN OVER-THE-WIRE POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1