BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER

    MDR report key: 8888550 · Received August 13, 2019

    Report

    Report Number
    1820334-2019-01999
    Event Type
    Injury
    Date Received
    August 13, 2019
    Date of Event
    August 12, 2019
    Report Date
    October 30, 2019
    Manufacturer
    COOK INC
    Product Code
    GBO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: CONCOMITANT MEDICAL PRODUCT RECEIVED ON 28AUG2019. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL, AS WELL AS A VISUAL INSPECTION AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS COMPLETED. ONE USED 8.5FR CATHETER WAS RETURNED WITH THE HUB SEPARATED FROM THE CATHETER. NO DAMAGE WAS NOTED TO THE FLARE OF THE CATHETER. THE CAP'S INNER DIAMETER WAS MEASURED WITHIN TOLERANCE. INVESTIGATORS COULD NOT ATTEMPT TO RECREATE THE REPORTED FAILURE BECAUSE THE HUB WAS RETURNED SEPARATED FROM THE CATHETER TUBING. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. COOK DID NOT RECEIVE LOT INFORMATION FROM THE USER FACILITY. A GLOBAL SALES SHIPMENT REPORT WAS CONDUCTED FOR THREE YEARS OF SALES FOR THE COMPLAINT DEVICE RPN. THE CUSTOMER BOUGHT ONE LOT OVER THIS TIME PERIOD. COOK COMPLETED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER, 9812157. THE REVIEW REVEALED NO RELATED NONCONFORMANCES. A SOFTWARE SEARCH WAS COMPLETED AND NO ADDITIONAL COMPLAINTS WERE FOUND. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO RELATED NON-CONFORMANCES, AND NO OTHER LOT RELATED COMPLAINTS FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: WARNINGS: ¿IF A CATHETER HAS BECOME MALPOSITIONED OR IF DRAINAGE CEASES, THE CATHETER SHOULD BE PROMPTLY EXCHANGED OR REMOVED. INSTRUCTIONS FOR USE: ONCE CATHETER IS IN DESIRED LOCATION, REMOVE ANY WIRE GUIDES, TROCARS, OR STIFFENERS, ALLOWING THE CATHETER TO FORM ITS CONFIGURATION. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE INFORMATION PROVIDED, INSPECTION OF RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT THE ROOT CAUSE CAN BE TRACED TO A COMPONENT FAILURE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK 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 ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER - OCCUPATION: CHARGE TECH. PMA/510(K) #: EXEMPT. 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 AN ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER WAS PLACED IN A PATIENT FOR A NEPHROSTOMY PROCEDURE (DESCRIBED BY THE INITIAL REPORTER AS "DOUBLE-J INSERTION W/ NON-LOCKING NEPHROSTOMY"). AS REPORTED, THREE DAYS AFTER THE INITIAL PLACEMENT, "PATIENT WOKE (IN THE) MORNING WITH A FULL BAG. WHEN THE PATIENT TRIED TO GET OUT OF BED, THE CATHETER CAME APART." THE CATHETER WAS FOUND SEPARATED AT THE JUNCTION BETWEEN THE CATHETER TUBE AND THE HUB. ALL PORTIONS WERE RETRIEVED AND THE CATHETER WAS EXCHANGED FOR ANOTHER OF THE SAME TYPE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680860 ULTRATHANE PIGTAIL MULTIPURPOSE DRAINAGE CATHETER GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY GBO COOK INC N/A 9812157

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention