BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DQY CATHETER, PERCUTANEOUS

    MDR report key: 6714772 · Received July 14, 2017

    Report

    Report Number
    1820334-2017-01655
    Event Type
    Injury
    Date Received
    July 14, 2017
    Report Date
    November 1, 2017
    Manufacturer
    COOK INC
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    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, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND TRENDS OF THE DEVICE 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD 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. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. .

    Description of Event or Problem · 1

    GILBERT, RUTHE, ET AL,. IMPREGNATED CENTRAL VENOUS CATHETERS FOR PREVENTION OF BLOODSTREAM INFECTION IN CHILDREN (THE CATCH TRIAL): A RANDOMIZED CONTROLLED TRIAL. LANCET 2016; 387:1732-42. THE ABOVE REFERENCED JOURNAL ARTICLE REPORTS THE RESULTS OF A RANDOMIZED TRIAL COMPARING THREE TYPES OF CENTRAL VENOUS CATHETERS FOR THE PREVENTION OF BLOODSTREAM INFECTION. PATIENTS WERE RANDOMIZED TO THREE CATHETER STUDY GROUPS: STANDARD CENTRAL VENOUS CATHETERS (N= 502), ANTIBIOTIC- IMPREGNATED CENTRAL VENOUS CATHETERS (N= 486) OR HEPARIN-IMPREGNATED CENTRAL VENOUS CATHETERS (N=497.) BLOODSTREAM INFECTION OCCURRED IN 18 PATIENTS (4%) OF THOSE IN THE STANDARD CATHETER GROUP, 7 PATIENTS (1%) IN THE ANTIBIOTIC-IMPREGNATED CATHETER GROUP AND 17 PATIENTS (3%) IN THE HEPARIN-IMPREGNATED GROUP. THIS REPORT ADDRESSES THE PATIENTS ENTERED INTO THE ANTIBIOTIC IMPREGNATED CENTRAL VENOUS CATHETER GROUP. THE RESULT SUMMARY INDICATES THAT ANTIBIOTIC-IMPREGNATED CENTRAL VENOUS CATHETERS SIGNIFICANTLY REDUCED THE RISK OF BLOODSTREAM INFECTION COMPARED WITH STANDARD AND HEPARIN-IMPREGNATED CATHETERS. THIS IS ONE OF SIX MEDWATCH REPORTS BEING SUBMITTED TO ADDRESS THE EVENTS IDENTIFIED IN THE JOURNAL ARTICLE REFERENCED ABOVE. REFERENCE MDR NUMBERS 1820334-2017-00827, 1820334-2017-01654, 1820334-2017-01655, 1820334-2017-01656, 1820334-2017-01657 AND 1820334-2017-01658.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496748 DQY CATHETER, PERCUTANEOUS DQY COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening