BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Cook Spectrum

    MDR report key: 6660053 · Received June 22, 2017

    Report

    Report Number
    1820334-2017-01362
    Event Type
    Malfunction
    Date Received
    June 22, 2017
    Date of Event
    May 22, 2017
    Report Date
    December 13, 2017
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002536005
    PMA / PMN Number
    K033843
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BRAND NAME: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. CORRECTED INFORMATION: DEVICE WAS RECEIVED ON 23JUN2017, AFTER THE INITIAL REPORT WAS SUBMITTED. INVESTIGATION - EVALUATION : A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET DEVICE WAS RETURNED IN OPENED, AND UNUSED CONDITION. THE TIP OF THE WIRE GUIDE HOLDER WAS BROKEN INTO TWO SEPARATE PIECES. THE WIRE GUIDE DISPENSER MATERIAL WAS LODGED IN THE J-TIP STRAIGHTENER; THE FRAGMENT WAS REMOVED IN ORDER TO TAKE MEASUREMENTS. THE OD OF THE SNAP ON THE DISPENSER AND THE ID OF THE SNAP END OF J-IP STRAIGHTENER MEASURED WITHIN SPECIFICATION LIMITS. 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 THAT THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE WIRE GUIDE HOLDER IS INTRODUCED IN THE PACKAGE DURING THE PACKAGING STAGE OF THE PRODUCT. THE J-TIP STRAIGHTENER IS SNAPPED TO THE WIRE GUIDE DISPENSER PRIOR TO SHIPPING. THE PACKAGE IS INSPECTED FOR DEFECTS DURING THE PACKAGING AND POST STERILIZATION STAGES. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE FOR THE BROKEN TIP IS LIKELY RELATED TO HANDLING DURING THE PACKAGING, STERILIZATION, TRANSPORTATION OR STORAGE OF THE DEVICE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT THE TIP OF GUIDE WIRE HOLDER FROM A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET WAS BROKEN. THE EVENT WAS NOTED PRIOR TO PATIENT CONTACT. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION, HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440378 Cook Spectrum FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC N/A 00827002536005

    Patients

    Seq Age Sex Outcome Treatment
    1