BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET

    MDR report key: 7539964 · Received May 24, 2018

    Report

    Report Number
    1820334-2018-01524
    Event Type
    Injury
    Date Received
    May 24, 2018
    Report Date
    September 11, 2018
    Manufacturer
    COOK INC
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE PATIENT INDICATED HE HAD BEEN USING THE SAME FEEDING TUBE THE PAST FEW YEARS, AND PROVIDED AN IMAGE OF A LABEL FOR THE WOGS-1200 WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY SET, WHICH SHOWED A LOT NUMBER OF 7051596. THE PRODUCT IS NOT AVAILABLE FOR RETURN; THUS, A DEVICE FAILURE ANALYSIS COULD NOT BE PERFORMED. THE DEVICE HISTORY RECORD FOR THE WOGS-1200 WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY SET FROM LOT NUMBER 7051596 REVEALED ZERO NON-CONFORMANCES. THE DEVICE HISTORY RECORD FOR THE ULT12.0-38-35-P-12S-WOGS ULTRATHANE WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY CATHETER FROM THE LOT NUMBER NI7051595 REVEALED SEVERAL NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. ALTHOUGH EACH OF THESE NON-CONFORMANCES WERE EITHER SCRAPPED OR REWORKED, THE HIGH AMOUNT OF NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT FROM THIS SPECIFIC LOT NUMBER MAKE IT REASONABLE TO SUGGEST THAT THIS FAILURE IS MANUFACTURING RELATED. HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO EVIDENCE TO SUGGEST THERE IS NON-CONFORMING PRODUCT IN HOUSE OR IN THE FIELD A REVIEW OF OUR COMPLAINT MANAGEMENT SYSTEM INDICATED THIS TO BE THE ONLY REPORTED FAILURE FOR LOT NUMBER 7051596. THE INSTRUCTIONS FOR USE ALSO WARNS THAT THE PRODUCT CONTAINS NATURAL RUBBER LATEX, WHICH MAY CAUSE ALLERGIC REACTIONS. THE TECHNICAL FILE FOR THIS PRODUCT INDICATED THAT BIOCOMPATIBILITY TESTING WAS PERFORMED ON DEVICES IN CONTACT WITH THE TISSUE FOR A PERIOD GREATER THAN 30 DAYS, INDICATING THAT TESTING WAS FOUND TO PASS THE ESTABLISHED REQUIREMENTS. IT IS ALSO REASONABLE TO SUGGEST THAT THE SITE INFECTION DERIVES FROM GENERAL IRRITATION THAT OCCURS AT THE FEEDING TUBE STOMA SITES FROM THE TUBE RUBBING AGAINST THE PATIENT'S SKIN. IT IS ALSO REASONABLE TO SUGGEST THAT THE ADDITIONAL REPORTED FAILURE MODES (CLOGGING AND PINHOLES) CAUSED A CASCADING LEAKAGE EVENT TO OCCUR, WHERE FEEDING TUBE FORMULA OR BODY FLUIDS LEAKED AROUND THE SKIN EXIT SITE. THE FEEDING TUBE FORMULA COULD HAVE ALSO DRIPPED DOWN THE SIDE OF THE FEEDING TUBE AT THE STOMA SITE DURING ADMINISTRATION, LEADING TO AN INFECTION. HOWEVER, THESE INSTANCES CANNOT BE CONFIRMED. THERE IS NO INFORMATION REGARDING THE MAINTENANCE OR PREVENTATIVE MEASURES SUCH AS SECURING, ANTIBIOTIC OINTMENT OR DRAIN SPONGES AROUND THE STOMA SITE THAT COULD LESSEN RISK OF INFECTION OR IRRITATION. THERE IS NO INFORMATION STATING HOW THE INFECTION WAS TREATED. THERE IS NO INFORMATION ABOUT A FEEDING AND FLUSHING REGIMEN. IT IS NOT KNOWN IF MEDICATIONS ARE ADMINISTERED THROUGH THE TUBE AND IF THESE ARE CRUSHED TABS THAT COULD CLOG A TUBE. BASED ON THE REVIEW OF THE DEVICE HISTORY RECORD, IT IS ALSO REASONABLE TO SUGGEST THAT THE MANUFACTURE OF THE DEVICE MAY HAVE ATTRIBUTED TO THE FAILURE. HOWEVER, THIS CANNOT BE CONFIRMED. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED 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

    ADDITIONAL INFORMATION HAS NOT BEEN REPORTED SINCE THE SUBMISSION OF THE INITIAL REPORT ON 05/24/2018.

    Additional Manufacturer Narrative · 1

    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 THE PATIENT HAS BEEN USING WILLS-OGLESBY PERCUTANEOUS GASTROSTOMY SETS FOR COMPLETE DIETARY NUTRITION SINCE 1997. AS REPORTED, THIS PATIENT USES APPROXIMATELY SIX TUBES A YEAR AND HAS, IN THE PAST, DEVELOPED A SITE INFECTION. ADDITIONAL INFORMATION REGARDING THE SEVERITY AND TREATMENT OF INFECTION HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382392 ULTRATHANE WILLS-OGLESBY SINGLE LUMEN PERCUTANEOUS GASTROSTOMY SET KNT TUBES, GASTROINTESTINAL KNT COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other