BEUDAMED
    FDA Adverse Event Injury Summary report: N

    Cook Spectrum

    MDR report key: 6667153 · Received June 26, 2017

    Report

    Report Number
    1820334-2017-01399
    Event Type
    Injury
    Date Received
    June 26, 2017
    Date of Event
    May 23, 2017
    Report Date
    December 1, 2017
    Manufacturer
    COOK INC
    Product Code
    FOZ
    UDI-DI
    00827002478251
    PMA / PMN Number
    K081113
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    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: COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET. INVESTIGATION-SUMMARY: A REVIEW OF DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, IFU, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER SET" (LOT 7792182), WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS PERFORMED. THE DEVICE WAS RETURNED IN USED CONDITION; THE EXTENSION TUBE WITH THE RED HUB WAS SEPARATED AT THE MANIFOLD. THERE WAS NO MATERIAL INSIDE THE MANIFOLD. THERE WAS A SMOOTH TRANSITION OF THE PIN GAGE THROUGH THE LUMEN. THE LENGTH, OUTER DIAMETER (OD) AND INNER DIAMETER (ID) OF THE RED EXTENSION TUBE WERE MEASURED AND ALL WERE WITHIN SPECIFICATION. THE TUBING IS INSERT MOLDED TO THE MANIFOLD AND THE IMAGE OF THE SEPARATION APPEARS TO BE SHEARED RATHER THAN PULLED. A DOCUMENT-BASED INVESTIGATION EVALUATION SHOWED NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. A REVIEW OF COMPLAINT HISTORY FOR THE PRODUCT LOT REVEALED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO COMPLAINT LOT NUMBER 7792182. BASED ON THE AVAILABLE INFORMATION AND EVALUATION OF THE RETURNED DEVICE, IT IS NOT CLEAR IF THE LEADING CAUSE TO THIS EVENT MIGHT BE ASSOCIATED WITH INTENSE MOBILIZATION OF THE PATIENT (WHICH COULD DETERMINE AN EVENTUAL CATHETER DISCONNECTION), THE MEDICAL PROCEDURE OR A POTENTIAL MALFUNCTION OF THE DEVICE. HOWEVER, THERE IS NO DEFINITIVE EVIDENCE THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. WHILE IT IS FEASIBLE THAT THE DEVICE MAY HAVE BECOME KINKED OR FOLDED OR WAS POWER INJECTED ABOVE PREDETERMINED LIMITS CAUSING THE TUBING TO BREAK, THE ROOT CAUSE IS INCONCLUSIVE PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. .

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A PATIENT UNDERWENT PLACEMENT OF A COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS CATHETER ON (B)(6) 2017. THE CUSTOMER STATES THAT THE CENTER LUMEN OF THE TRIPLE LUMEN DEVICE WITH THE IV TUBING CONNECTED WAS DISCOVERED LYING IN THE PATIENT'S BED. THE CIRCUMSTANCES AND FORCES APPLIED TO THE DEVICE LEADING TO THE EVENT ARE NOT KNOWN. THE LINE WAS IMMEDIATELY REMOVED AND A NEW ONE INSERTED. NO FURTHER EVENT OR PATIENT DETAILS WERE PROVIDED. 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
    448970 Cook Spectrum FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK INC N/A 00827002478251

    Patients

    Seq Age Sex Outcome Treatment
    1