BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 20207242 · Received September 12, 2024

    Report

    Report Number
    1820334-2024-01214
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 28, 2024
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002089563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4: 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. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. SUMMARY OF EVENT: AS REPORTED, A PERFORMER INTRODUCER WAS MISSING FROM ITS PACKAGING. PER THE REPORTER, A SEAL WAS NOT EVIDENT ON THE DISTAL END OF THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE BOTTOM SEAL WAS MISSING AND THERE IS NO EVIDENCE IT WAS EVER SEALED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. COOK INVESTIGATED ALL LOTS MANUFACTURED AND CHECKED BY THE SAME PERSONNEL DURING THE SAME WEEK AS THE COMPLAINT LOT AND FOUND NO RELEVANT NON-CONFORMANCES. A DATABASE SEARCH FOR ALL FINAL LOTS FROM INSPECTED DEVICES REVEALED NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FROM THE FIELD. THE DEVICE INSTRUCTIONS FOR USE (IFU) STATES, ¿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 THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD, AND COOK HAS CONCLUDED THIS TO BE AN ISOLATED INCIDENT. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A MANUFACTURING AND QUALITY CONTROL DEFICIENCY CONTRIBUTED TO THIS EVENT. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    AS REPORTED, A PERFORMER INTRODUCER WAS MISSING FROM ITS PACKAGING. PER THE REPORTER, A SEAL WAS NOT EVIDENT ON THE DISTAL END OF THE PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1592425 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G08956 15431040 00827002089563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown