BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 11196614 · Received January 19, 2021

    Report

    Report Number
    1820334-2021-00122
    Event Type
    Malfunction
    Date Received
    January 19, 2021
    Date of Event
    January 13, 2021
    Report Date
    June 24, 2021
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002096912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DESCRIPTION OF EVENT: AS REPORTED, UPON RECEIPT OF THREE PERFORMER INTRODUCERS, UNKNOWN SMALL WHITE PARTICLES WERE NOTED WITHIN THE PACKAGES AND ON THE SHEATHS. THE DEVICES DID NOT MAKE PATIENT CONTACT. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWINGS, THE INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA, AND TRENDS. THE COMPLAINANT RETURNED THREE RCFW-16.0P-38-30-RB UNUSED TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE SHOWED: THREE SEALED DEVICES RECEIVED. INSPECTION FOUND WHITE FOREIGN MATTER PARTICLES IN THE POUCH. THE REPORTED FAILURE WAS EVIDENT TO INVESTIGATORS. SUPPLIER INVESTIGATION: CUSTOMER COULD NOT PROVIDE A SAMPLE OF THE DEFECT TO OLIVER, THEREFORE SAMPLE WAS SENT TO THE CUSTOMERS LAB FOR FTIR TESTING. THE REPORT SHOWED THE WHITE PARTICLES TO BE THE ADHESIVE APPLIED TO THE TYVEK. THIS IS PARENT MATERIAL AND WOULD NOT BE CONSIDERED FOREIGN MATERIAL. PRODUCT HAD BEEN PLACED INTO THE POUCH PRIOR TO THE ADHESIVE PARTICLES BEING FOUND. THESE PARTICLES FOUND ARE LIKELY DUE TO THE OBJECT INSERTED INTO THE POUCH SCRAPING AGAINST THE COATED TYVEK. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: "HOW SUPPLIED SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY , COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. IT WAS CONCLUDED THAT THE DEVICE ASPECT IN QUESTION WAS VISUALLY/FUNCTIONALLY INSPECTED BY QUALITY CONTROL AND NO RELATED GAPS IN PRODUCTION OR PROCESSING CONTROLS WERE NOTED. BASED ON THE PROVIDED EVIDENCE, SUPPLIER INVESTIGATION AND THE COMPLETED INVESTIGATION, COOK HAS CONCLUDED TRANSPORTATION CONTRIBUTED TO THIS INCIDENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. COOK WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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 NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. OCCUPATION: INVENTORY ANALYST. PMA/510(K) NUMBER = K171999. 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

    AS REPORTED, UPON RECEIPT OF THREE PERFORMER INTRODUCERS, UNKNOWN SMALL WHITE PARTICLES WERE NOTED WITHIN THE PACKAGES AND ON THE SHEATHS. THE DEVICES DID NOT MAKE PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91158 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G09691 13530006 00827002096912

    Patients

    Seq Age Sex Outcome Treatment
    1