BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7848011 · Received September 5, 2018

    Report

    Report Number
    1820334-2018-02514
    Event Type
    Injury
    Date Received
    September 5, 2018
    Date of Event
    July 31, 2018
    Report Date
    January 3, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    PMA / PMN Number
    K033843
    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 HAS PREVIOUSLY BEEN REPORTED, IS UNKNOWN OR IS UNAVAILABLE. DEVICE EVALUATION FIVE USED DEVICES WERE RETURNED FOR EVALUATION; HOWEVER, DEVICES WERE UNABLE TO BE RECONCILED WITH SPECIFIC CASES. ALL DEVICES WERE NOT KINKED, BIOMATTER WAS PRESENT, SHOWED NO SIGN OF DAMAGE ON MANIFOLDS OR EXTENSION TUBING AND ALL DEVICES PASSED A TUG TEST. ALL DEVICES FAILED LEAK TESTING. ONE RED HUB HAD DEFORMATION/INDENTATIONS IN THE MATERIAL NEAR THE WING AREA. A DRY, WHITE, SUBSTANCE WAS NOTED TO COAT THE HUB. ONE WHITE HUB HAD DEFORMATION/INDENTATIONS IN THE MATERIAL NEAR THE WING AREA. A WHITE SUBSTANCE WAS PRESENT ON THE CLAMP. A YELLOW SUBSTANCE WAS PRESENT INSIDE THE THREADS. A 7MM CRACK WAS NOTED ON A BLUE HUB IN LINE WITH THE WING. INDENTATIONS WERE ALSO OBSERVED, AND THE HUB WAS COVERED WITH A WHITE SUBSTANCE. THE GATE DOT WAS NOTED TO BE ON THE OPPOSITE WING OF THE CRACK. INVESTIGATION A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THIS CASE TO BE THE ONLY REPORTED COMPLAINTS FOR THIS LOT NUMBER. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY AND FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO NOTABLE GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. 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. 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.

    Additional Manufacturer Narrative · 1

    COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY. FOZ - CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT. DEVICE RETURN INFORMATION: FIVE USED DEVICES HAVE BEEN RETURNED TO COOK INC. FOR EVALUATION, HOWEVER, THERE IS NOT ENOUGH INFORMATION TO DETERMINED WHICH INCIDENT EACH DEVICE WAS ASSOCIATED WITH. THE PATIENT REQUIRED MEDICAL INTERVENTION. AN ADDITIONAL PROCEDURE TO REMOVE AND REPLACE THE DEVICE WAS REQUIRED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. [MW5079103.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED A 5FR TRIPLE LUMEN CENTRAL VENOUS CATHETER PLACED ON (B)(6) 2018 WAS FOUND CRACKED ON (B)(6) 2018. THE LINE WAS REMOVED AND REPLACED ON AN UNKNOWN DATE. ADDITIONAL PATIENT INFORMATION IS UNKNOWN AND WILL NOT BE PROVIDED. AS REPORTED, THREE OF NINE PATIENT'S REPORTED BY THIS FACILITY DEVELOPED INFECTIONS THAT WERE TREATED APPROPRIATELY. IT IS UNKNOWN WHICH EVENT CORRESPONDS TO THE POSITIVE INFECTION CULTURES. THIS REPORT IS ASSOCIATED WITH INQUIRY MW5079103 RECEIVED ON 23AUG2018. THE DEVICE AND LOT INFORMATION WAS PROVIDED IN MW5079103.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690177 FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC NA 8690105

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention