BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM

    MDR report key: 8199017 · Received December 27, 2018

    Report

    Report Number
    1820334-2018-03890
    Event Type
    Malfunction
    Date Received
    December 27, 2018
    Date of Event
    November 26, 2018
    Report Date
    April 24, 2019
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002237636
    PMA / PMN Number
    K081113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D10: PRODUCT RECEIVED ON 07MAR2019. H6 ¿ RESULTS CODE: APPROPRIATE TERM/CODE NOT AVAILABLE (4247) ¿ CUSTOMER DISSATISFACTION. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AS WELL AS A FUNCTIONAL TEST AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE TRIPLE LUMEN CATHETER WITH A STIFFENER LOCATED IN THE LUMEN OF THE RED HUB WAS RETURNED FOR INVESTIGATION. ONLY TWO NEEDLELESS CONNECTORS WERE RETURNED. POTENTIAL BIOLOGICAL MATTER WAS PRESENT WITHIN THE BLUE AND WHITE HUB EXTENSION TUBES. NO SURFACE DAMAGE WAS NOTED ON THE DEVICE, AND THE SIDEPORTS APPEARED TO BE UNOBSTRUCTED. THE STIFFENER WAS REMOVED FROM THE DEVICE, AND IT WAS OBSERVED TO CONTAIN BROWNISH DISCOLORATION ON THE SURFACE. NO DAMAGE WAS OBSERVED ON THE RED, WHITE OR BLUE HUBS. EACH HUB WAS FLUSHED WITH ROOM TEMPERATURE WATER, AND NO RESISTANCE WAS NOTED WHEN FLUSHING ANY OF THE HUBS. THE RED AND WHITE HUB FLUSHED CLEAR LIQUID, HOWEVER, THE BLUE HUB FLUSHED WITH SLIGHTLY DISCOLORED LIQUID. NO RESISTANCE WAS FELT WHEN FLUSHING EITHER OF THE NEEDLELESS CONNECTORS. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. IT WAS CONCLUDED THAT SUFFICIENT ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DEVICE DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 8881926 SHOWED NO NONCONFORMANCES. IT WAS REVEALED THAT FOUR NONCONFORMANCES WERE FOUND FOR COMPLETE CATHETER LOT IC8563694. ONE NONCONFORMANCE WAS DETERMINED TO BE UNRELATED TO THIS INCIDENT. ONE NONCONFORMANCE INVOLVED FOUR DEVICES WITH ¿COATING IN UNSPECIFIED AREA,¿ IN WHICH ALL AFFECTED DEVICES WERE SCRAPPED. ANOTHER RELATED NONCONFORMANCE INVOLVED TWO DEVICES WITH ¿COATING ON THE MANIFOLD,¿ IN WHICH BOTH DEVICES WERE SCRAPPED. THE FINAL NONCONFORMANCE INVOLVED ONE DEVICE WITH ¿INCORRECT PLACEMENT OF MARKING (0-5CM). THE AFFECTED DEVICE WAS SCRAPPED. COMPLETE CATHETER LOT IC8593901 SHOWED THREE NONCONFORMANCES, AS ONLY ONE WAS FOUND TO BE UNRELATED TO THIS INCIDENT. ONE RELATED NONCONFORMANCE INVOLVED SIX SCRAPPED DEVICES WITH ¿COATING IN I.D¿, AND ANOTHER NONCONFORMANCES AFFECTING ONE DEVICE WITH ¿526 PRODUCT CONTACTED UNCONTROLLED SURFACE¿ THAT WAS LATER SCRAPPED. IN THE FINAL COMPLETE CATHETER LOT IC8659844, THREE NONCONFORMANCES WERE FOUND. TWO OF THOSE NONCONFORMANCES WERE FOUND TO BE UNRELATED TO THE INCIDENT. THE ONE NONCONFORMANCES THAT WAS RELATED INVOLVED TWO DEVICES WITH ¿251, INCORRECT COATING LENGTH,¿ IN WHICH BOTH DEVICES WERE SCRAPPED. COMPLETE CATHETER LOT IC8653069 SHOWED ZERO NONCONFORMANCES. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS REPORTED FOR LOT 881926. IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: SUGGESTED CATHETER MAINTENANCE "...THE ANTIMICROBIAL AGENTS MINOCYCLINE AND RIFAMPIN CONTAIN YELL/ORANGE PIGMENTS. SOME COLORATION OF THE SPECTRUM OR SPECTRUM GLIDE CATHETERS IS NORMAL." INSTRUCTIONS FOR USE "... PREPARE THE CATHETER FOR INSERTION BY FLUSHING EACH OF THE LUMENS..." BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. MOST LIKELY THE DEVICE WAS FLUSHING OUT EXCESSIVE ABRM COATING. THE IFU STATES THAT, ¿SOME COLORATION OF THE COOK SPECTRUM CATHETERS IS NORMAL.¿ PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR 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.

    Description of Event or Problem · 0

    NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

    Additional Manufacturer Narrative · 1

    BRAND NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY. 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 THAT WHILE FLUSHING THE CATHETER INCLUDED IN THE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER TRAY, DISCOLORED FLUID WAS DISCOVERED. THE CATHETER WAS FLUSHED WITH NORMAL SALINE PRIOR TO INSERTION, AND THE USER OBSERVED BROWN FLUID UPON FLUSHING. THE CATHETER DID NOT MAKE PATIENT CONTACT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039611 COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC G23763 8881926 00827002237636

    Patients

    Seq Age Sex Outcome Treatment
    1