BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET

    MDR report key: 7923136 · Received October 1, 2018

    Report

    Report Number
    1820334-2018-02754
    Event Type
    Injury
    Date Received
    October 1, 2018
    Report Date
    November 16, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, AND QUALITY CONTROL WERE 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH STATES THE PROPER WARNINGS, PRECAUTIONS, AND INSTRUCTIONS FOR USE. FURTHERMORE, A REVIEW OF THE DEVICE SPECIFICATIONS WAS CONDUCTED, AND NO GAPS WERE FOUND. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K161496. PATIENT CODE: NO CODE AVAILABLE - ADDITIONAL PROCEDURE REQUIRED TO REPLACE LINE. 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 4FR TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER WAS PLACED IN A MALE PATIENT IN (B)(6). THE PATIENT PRESENTED WITH A BROKEN HUB IN (B)(6) AND THE LINE WAS REPLACED. AFTER A FEW WEEKS, THE REPLACEMENT HUB WAS BROKEN, AND IS REPORTED ON MEDWATCH 1820334-2018-02696. THE HUBS WERE SAID TO HAVE BROKEN WHEN TIGHTENING DOWN THE CONNECTING TUBE. TO DATE, DESPITE MULTIPLE GOOD FAITH EFFORTS, ADDITIONAL PATIENT AND EVENT INFORMATION HAS NOT BEEN PROVIDED. AS REPORTED, BOTH INCIDENCES DID NOT HAVE AN ADVERSE EFFECT ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764154 TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention