BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

    MDR report key: 6261732 · Received January 18, 2017

    Report

    Report Number
    1820334-2017-00005
    Event Type
    Injury
    Date Received
    January 18, 2017
    Date of Event
    December 20, 2016
    Report Date
    December 20, 2016
    Manufacturer
    COOK INC
    Product Code
    LJS
    PMA / PMN Number
    K111244
    Report Source
    Manufacturer report
    Reporter Location
    NE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME) LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER. PMA #) ADDITIONAL - MISSING INFORMATION (K111244).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE TRENDS AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN, ACCORDINGLY A REVIEW OF THE MANUFACTURING RECORDS AND LOT COMPLAINT HISTORY COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. RISK MITIGATION ACTIVITIES ARE CURRENTLY BEING REVIEWED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT BLOOD WAS LEAKING NEAR THE HUB OF A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE. THE AMOUNT OF BLOOD LOSS WAS NOT SPECIFIED. THE PICC LINE WAS EXPLANTED AND THE PATIENT REQUIRED HOSPITALIZATION OVER A WEEKEND IN ORDER TO MAINTAIN REQUIRED THERAPY. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE TO IMPLANT A REPLACEMENT CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. NO FURTHER INFORMATION WAS PROVIDED RELATING TO THE CURRENT PATIENT STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42553 TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R