BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7901675 · Received September 24, 2018

    Report

    Report Number
    1820334-2018-02741
    Event Type
    Injury
    Date Received
    September 24, 2018
    Date of Event
    August 26, 2018
    Report Date
    December 18, 2018
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002516700
    PMA / PMN Number
    K033843
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. BRAND NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. PATIENT CODE: NO CODE AVAILABLE - THE DEVICE WAS REMOVED/REPLACED TO PREVENT POTENTIAL INFECTION. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED BY COOK INC. REPRESENTATIVE ON 02OCT2018 STATED THE FOLLOWING: DATE AWARE IS 05SEP218 AND PATIENT WEIGHT WAS (B)(6) . DEVICE EVALUATION THE REPORTED USED DEVICE WAS RETURNED TO COOK INC. FOR EVALUATION. VISUAL INSPECTION VERIFIED THE BLUE HUB WAS CRACKED. THE CRACK WAS ALONG THE WING OF THE HUM AND MEASURED 0.8CM IN LENGTH. FUNCTIONAL TESTING WAS PERFORMED AND THE LEAKAGE WAS OBSERVED AT THE CRACK ON THE BLUE HUB. INVESTIGATION A DOCUMENT-BASED INVESTIGATION REVIEWED THE FOLLOWING: INSTRUCTIONS FOR USE, QUALITY CONTROL, SPECIFICATIONS, COMPLAINT HISTORY, DEVICE HISTORY RECORDS AND MANUFACTURING INSTRUCTIONS. THE DEVICE HISTORY RECORD WAS REVIEWED FOR EVERY PROCESS FOR THE CATHETERS OF LOT NUMBER 8497337. PROCESSES REVIEWED STARTED FROM INCOMING INSPECTION OF THE RAW MATERIAL (CATHETER ASSEMBLY WITH HUB) THROUGH THE ABRM COATING PROCESS UNTIL THEY REACH THE END PRODUCT OF C-UTLMY-501J-WCE-ABRM-HC OF LOT NUMBER 8497337. IN ADDITION, A SUPPLIER EVALUATION WAS REQUESTED FOR A REVIEW OF THE RAW MATERIALS. A SUPPLIER EVALUATION WAS REQUESTED FROM THE SUPPLIER OF THE CATHETER RAW MATERIAL. THE SUPPLIER FOUND THAT NO NON-CONFORMING PRODUCT HAS BEEN IDENTIFIED IN-HOUSE OR IN THE FIELD BASED ON THEIR INVESTIGATION. THE SUPPLIER ALSO REVIEWED THE MANUFACTURING LOT INFORMATION FOR THESE HUBS AND FOUND THAT THERE WERE NOT ANY ANOMALIES NOTED IN THE MANUFACTURING METHODS NOR PROCESS OUTPUTS WHEN COMPARED TO LOTS FROM TWO YEARS PRIOR. THE DEVICE HISTORY RECORD FOR EACH LOT NUMBER IN EACH SUB ASSEMBLY THAT MAKES UP LOT 8497337 WAS REVIEWED. NO RELATED NONCONFORMANCES WERE NOTED DURING MANUFACTURING. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. CONCLUSION BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME, HOWEVER APPROPRIATE MEASURES HAVE BEEN INITIATED TO INVESTIGATE THIS FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER (CVC) WAS FOUND TO HAVE A CRACK IN THE LINE DURING MONITORING/ASPIRATION. TO DATE, ADDITIONAL PATIENT AND EVENT INFORMATION HAS BEEN REQUESTED BY NOT YET PROVIDED BY THE FACILITY. AS REPORTED, THIS DEVICE ISSUE DID NOT CAUSE THE PATIENT HARM, HOWEVER, THE DEVICE WAS REMOVED/REPLACED THE FOLLOWING DAY TO PREVENT POSSIBLE INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED ON 11DEC2018. THE LINE HAD BEEN INSERTED ON (B)(6) 2018 AND WAS SUTURED IN PLACE. THE LUMEN WAS USED FROM THE OUTSET. IT HAD 3 WAY TAPS ATTACHED WITH INOTROPIC MEDICATIONS INFUSING. THE LUMEN AND LINES WERE NOT DISTURBED PRIOR TO THE INCIDENT. FOR A PERIOD OF TIME PRIOR TO IDENTIFYING THE PROBLEM THERE HAD BEEN MEDICATION DELIVERY ISSUES THROUGH THE LUMEN. AS THE LUMEN WAS BEING USED FOR INOTROPES AND THE DELIVERY ISSUE WAS COMPROMISING THE PATIENT¿S HEMODYNAMICS THE INOTROPES WERE MOVED TO ANOTHER LINE. ONCE THIS HAD BEEN COMPLETED THE 3 WAY TAPS ATTACHED TO THE LUMEN WERE REMOVED EASILY AND A 10ML BD PLASTIPAK LUERLOCK SYRINGE WAS ATTACHED. THE LUMEN INITIALLY BLED BACK EASILY BUT THEN SUDDENLY, AND WITHOUT ANY CHANGE TO ATTACHMENT OF THE LUMEN, SIGNIFICANT VOLUMES OF AIR BEGAN ENTRAINING INTO THE SYRINGE AND NO FURTHER BLOOD COULD BE ASPIRATED. ON REMOVAL OF THE LUERLOCK SYRINGE THE LARGE CRACK WAS NOTICED IN THE HUB OF THE LUMEN. THIS WAS PRESUMED TO BE THE SOURCE OF AIR ENTRAINMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743626 FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC NA 8497337 00827002516700

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention