BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK SPECTRUM

    MDR report key: 9610562 · Received January 21, 2020

    Report

    Report Number
    1820334-2020-00168
    Event Type
    Malfunction
    Date Received
    January 21, 2020
    Date of Event
    December 20, 2019
    Report Date
    March 25, 2020
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002478299
    PMA / PMN Number
    K081113
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE PRODUCT IS MARKED AS BEING AVAILABLE FOR RETURN, THE PRODUCT HAS NOT BEEN RECEIVED AND THE CUSTOMER HAS NOT RESPONDED TO REQUESTS FOR RETURN INFORMATION. IF THE PRODUCT IS RETURNED, THE COMPLAINT WILL BE UPDATED. INVESTIGATION - EVALUATION: IT WAS REPORTED TO COOK THAT THE WIRE GUIDE WITHIN A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET, C-UTLM-701J-RSC-ABRM-HC-RD, FROM LOT # 9982085, DIDN¿T ADVANCE SMOOTHLY AND UNRAVELED UPON REMOVAL. THIS INCIDENT WAS REPORTED BY QUEENSWAY CARLETON HOSP IN CANADA,ON (B)(6) 2020. THE PROCEDURE WAS ABORTED, AND A NEW ATTEMPT WAS STARTED WITH A NEW KIT. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL 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. COOK DID NOT CONCLUDE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. A REVIEW OF THE DESIGN HISTORY FILE FOUND THAT THE SUBJECT DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DHRS FOR THE PROVIDED COMPLAINT DEVICE LOT (9982085) AND THE RELATED WIRE GUIDE SUB-ASSEMBLY LOT REVEALED NO RECORDED NON-CONFORMANCES. A DATABASE SEARCH FOUND NO OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. AT THIS TIME, THERE IS NO EVIDENCE SUGGESTING THAT NONCONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU, [C_T_CTULMABRM_REV7] ¿COOK SPECTRUM CENTRAL VENOUS CATHETER MINOCYCLINE/RIFAMPIN ANTIBIOTIC IMPREGNATED POWER INJECTABLE,¿ PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: INSTRUCTIONS FOR USE: ¿4. SLIDE SAFE-T-J WIRE GUIDE STRAIGHTENER (POSITIONED ON DISTAL TIP OF WIRE GUIDE) OVER ¿J¿ PORTION OF WIRE GUIDE. PASS STRAIGHTENED WIRE GUIDE THROUGH NEEDLE; ADVANCE WIRE GUIDE 5-10 CM INTO VESSEL. IF STRAIGHT WIRE IS USED, ALWAYS ADVANCE SOFT, FLEXIBLE END THROUGH NEEDLE HUB AND INTO VESSEL. IF RESISTANCE IS ENCOUNTERED DURING WIRE GUIDE INSERTION, DO NOT FORCE WIRE GUIDE. WITHDRAWAL OF WIRE GUIDE THROUGH NEEDLE SHOULD BE AVOIDED; BREAKAGE MAY RESULT. 5. WHILE MAINTAINING WIRE GUIDE POSITION, WITHDRAW NEEDLE AND SAFE-T-J WIRE GUIDE STRAIGHTENER.¿ BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION, A ROOT CAUSE WAS ESTABLISHED AS A COMPONENT FAILURE WITHOUT A DESIGN OR MANUFACTURING DEFECT. IT¿S POSSIBLE THAT THE WIRE WAS MANIPULATED THROUGH THE NEEDLE DURING INSERTION OR REMOVAL, BUT THIS CANNOT BE CONFIRMED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT WAS RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    BRAND NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. (B)(6). OCCUPATION: MANAGER. 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 THE GUIDE WIRE OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET UNCOILED AND LENGTHENED UPON REMOVAL. THE GUIDE WIRE WAS NOT THREADING SMOOTHLY THROUGH THE CATHETER. WHEN IT WAS PULLED AND REMOVED, THE WIRE BEGAN TO "UNCOIL AND BECAME LENGTHENED AND LOOSE". THE ENTIRE PROCEDURE WAS ABORTED AND A NEW ATTEMPT AT THE PROCEDURE WAS STARTED WITH A NEW KIT. ADDITIONAL INFORMATION REGARDING PATIENT AND EVENT DETAILS HAS BEEN REQUESTED BUT IS NOT CURRENTLY AVAILABLE. NO OTHER ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74609 COOK SPECTRUM FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC NA 9982085 00827002478299

    Patients

    Seq Age Sex Outcome Treatment
    1