BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK SPECTRUM TURBO-JECT

    MDR report key: 7713512 · Received July 24, 2018

    Report

    Report Number
    1820334-2018-02169
    Event Type
    Injury
    Date Received
    July 24, 2018
    Date of Event
    June 25, 2018
    Report Date
    November 6, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    UDI-DI
    00827002237070
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICES WERE CONDUCTED DURING THE INVESTIGATION. THE REPORTED USED DEVICE WAS NOT RETURNED, HOWEVER, FOUR (4) UNUSED DEVICES FROM THE SAME LOT WERE RETURNED FOR EVALUATION. THE DEVICES WERE VISUALLY INSPECTED AND ALL FOUR (4) MET CATHETER DIAMETER AND COATING SPECIFICATIONS. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. THE CATHETER COMPONENT LOT WAS REVIEWED AND THREE DEVICES WERE SCRAPPED DURING MANUFACTURING. A COMPLAINT HISTORY SEARCH REVEALED ONE ADDITIONAL COMPLAINT FROM THIS FACILITY AGAINST THIS LOT. THE IFU STATES THAT CATHETER SIZE AND PLACEMENT CAN INFLUENCE CLOTTING AS THIS IS A KNOWN INHERENT RISK OF USING THIS DEVICE. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    SEE H10.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PRESUMED TO BE (B)(6) 2018, PER THREE DAYS AFTER PLACEMENT ON (B)(6) 2018. BRAND NAME: SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A SPECTRUM TURBO-JECT SINGLE LUMEN MINOCYCLINE/RIFAMPIN BEDSIDE POWER-INJECTABLE PICC (PERIPHERALLY INSERTED CENTRAL CATHETER) LINE WAS PLACED ON (B)(6) 2018 WITHOUT INCIDENT AND OPTIMAL TIP AT THE CAVOARTRIAL JUNCTION (CAJ) TO DELIVER CHEMOTHERAPY. THREE DAYS AFTER INSERTION, THE PATIENT PRESENTED WITH VENOUS THROMBOEMBOLISM (VTE) CONFIRMED THROUGH ULTRASOUND. AS REPORTED, THE RIGHT BASILIC WAS 4.4MM WHICH SHOULD HAVE BEEN SUFFICIENT FOR A 3FR PICC LINE. PER FACILITY PROTOCOL, THE LINES ARE FLUSHED TWICE PER DAY WITH HEPARIN. THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE ON (B)(6) 2018 TO REMOVE AND REPLACE THE ORIGINAL PICC LINE. THE PATIENT RECEIVED LOVENOX (ENOXAPARIN SODIUM) INJECTION TO TREAT THE VTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556277 COOK SPECTRUM TURBO-JECT LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC NA 8203488 00827002237070

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention