BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC

    MDR report key: 7177059 · Received January 9, 2018

    Report

    Report Number
    1820334-2018-00009
    Event Type
    Injury
    Date Received
    January 9, 2018
    Date of Event
    December 12, 2017
    Report Date
    March 29, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002345140
    PMA / PMN Number
    K132334
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A VISUAL EXAMINATION NOTED THE TUBING IS PARTIALLY SEVERED FROM THE WHITE HUB. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. ONE DEVICE WAS RETURNED FOR THE INVESTIGATION. A VISUAL EXAMINATION NOTED THE TUBING IS PARTIALLY SEVERED FROM THE WHITE HUB. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO OTHER NON-CONFORMANCES ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER (7970093). ADDITIONALLY, REVIEW OF THE MANUFACTURER'S COMPLAINT DATABASE FOUND NO OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER (7970093). BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION, INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THIS FAILURE MODE HAS BEEN ESCALATED PER INTERNAL PROCESSES.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT, 77 DAYS FOLLOWING IMPLANTATION, THE TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE BEGAN LEAKING FROM THE WHITE HUB AREA OF THE DEVICE. THE PRODUCT PROBLEM ULTIMATELY NECESSITATED THE EXCHANGING OF THE LINE. NO FURTHER COMPLICATIONS OR WERE REPORTED. THE CUSTOMER ALSO REPORTED DEVICE WAS BEING FLUSHED WITH SALINE AND THEN 1 ML HEPARIN LOCKED (10 UNITS/ML) TWICE A DAY . IN ADDITION, 1 ML OF 70 PERCENT ETHANOL WAS PLACED TO DWELL FOR FOUR HOURS EVERY SATURDAY, A TOTAL OF 12 ETHANOL LOCKS SINCE (B)(6) 2017 HAD BEEN PERFORMED. THE PICC LINE WAS BEING UTILIZED FOR INTERMITTENT MEDICATIONS: BUMETANIDE, ATIVAN (LORAZAPAM), CHLORATHIAZIDE AND POTASSIUM CHLORIDE. THE DEVICE HAS BEEN RETURNED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19761 TURBO-JECT® DOUBLE LUMEN POWER-INJECTABLE PICC LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A 00827002345140

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention