BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TURBO-JECT POWER INJECTABLE

    MDR report key: 7126406 · Received December 18, 2017

    Report

    Report Number
    1820334-2017-04458
    Event Type
    Malfunction
    Date Received
    December 18, 2017
    Date of Event
    December 6, 2017
    Report Date
    March 14, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002561946
    PMA / PMN Number
    K111244
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL EXAMINATION OF THE RETURNED DEVICE NOTED NO DAMAGE. THE HUBS WERE FOUND TO BE SECURE; THE MANIFOLD WAS SECURE. THE DEVICE WAS FLUSHED WITH WATER. A LEAK TEST WAS PERFORMED, AND NO LEAKS WERE NOTED. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT NUMBER 7953079 SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE INTERNATIONAL CUSTOMER REPORTED THAT THE TURBO-JECT POWER INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) COULD NOT BE PLACED IN THE PATIENT, DUE TO A FAULTY PURPLE HUB. THE PICC LINE WAS REPORTEDLY LEAKING IMMEDIATELY AT THE SITE OF THE HUB ON THE SIDE OF THE TRANSPARENT PORTION OF THE CATHETER. ANOTHER LINE HAD TO BE PLACED INSTEAD, BUT THE PLACEMENT OCCURRED IMMEDIATELY AFTER THE PROBLEM WAS DISCOVERED. THE DEVICE IS REPORTEDLY AVAILABLE FOR RETURN; HOWEVER, AS OF THE DATE OF THIS REPORT, THE DEVICE HAS NOT YET BEEN RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905251 TURBO-JECT POWER INJECTABLE LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 00827002561946

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention