BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

    MDR report key: 7791266 · Received August 16, 2018

    Report

    Report Number
    1820334-2018-02215
    Event Type
    Injury
    Date Received
    August 16, 2018
    Report Date
    January 10, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    PMA / PMN Number
    K081113
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION HAS PREVIOUSLY BEEN REPORTED, IS UNKNOWN OR IS UNAVAILABLE. DEVICE EVALUATION: THE REPORTED USED COMPLAINT DEVICE WAS RETURNED TO COOK INC. FOR EVALUATION. BIOMATTER WAS NOTED TO BE IN THE WHITE LUMEN, HOWEVER, FUNCTIONAL TESTING WAS UNABLE TO CONFIRM THE OCCLUSION. WATER WAS FLUSHED SUCCESSFULLY THROUGH ALL THREE LUMENS. ADDITIONALLY, THE BLUE HUB WAS FOUND TO HAVE A VERTICAL CRACK CAUSING WATER TO LEAK DURING FUNCTIONAL TESTING. INVESTIGATION: A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: INSTRUCTIONS FOR USE, QUALITY CONTROL AND MANUFACTURING INSTRUCTIONS. A REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. THE DEVICE MASTER RECORD WAS REVIEWED AND THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. THERE IS NO EVIDENCE TO SUGGEST THERE ARE NON-CONFORMING DEVICES IN HOUSE OR IN THE FIELD. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. THE APPROPRIATE MEASURES HAVE BEEN INITIATED TO INVESTIGATE THE CRACKED HUB DEVICE FAILURE. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. 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.

    Additional Manufacturer Narrative · 1

    COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. PATIENT CODE: MEDICAL INTERVENTION REQUIRED. DEVICE CODE: OCCLUSION WITHIN DEVICE, NO CODE AVAILABLE - ASPIRATION ISSUE . 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 COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS CHECKED FOR SAFETY AFTER IMPLANTATION. THE BLUE LUMEN WAS FOUND TO ONLY ASPIRATE AIR WHILE THE WHITE LUMEN WAS FOUND TO BE BLOCKED. THE RED LUMEN FUNCTIONED AS INTENDED. PERIPHERAL IV ACCESS WAS SECURED AND THE LINE WAS THEN REMOVED. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629552 FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention