BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 21095370 · Received January 7, 2025

    Report

    Report Number
    1820334-2025-00020
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    January 2, 2025
    Report Date
    June 10, 2025
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002479425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    . E1: NAME AND ADDRESS - (B)(6). G4: PMA/510(K) # - K240589 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. 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED BY A DISTRIBUTOR, UPON RECEIVING AND INSPECTING A MICROPUNCTURE TRANSITIONLESS ACCESS SET, IT WAS NOTED THAT THE STERILE PACKAGING WAS NOT SEALED. BECAUSE THIS WAS FOUND WITHIN A DISTRIBUTION FACILITY, THERE WAS NO IMPACT TO ANY PATIENT OR END USER. 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 RETURNED DEVICE WAS CONDUCTED AS WELL. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. PHYSICAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE BOTTOM SEAL WAS NOT PRESENT, AND FROSTING WAS NOT NOTED ON THE CLEAR FILM OF THE POUCH. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED RELEVANT COMPLAINTS FOR THIS LOT NUMBER. COOK INVESTIGATED ALL THE LOTS PACKAGED AND SEALED BY THE SAME PERSONNEL WITHIN THE SAME TIME AS THE COMPLAINT LOT AND FOUND NO RELEVANT COMPLAINTS HAVE BEEN REPORTED FROM THE FIELD FOR THE SAME FAILURE MODE. WITH THIS INFORMATION, COOK HAS CONCLUDED THAT THIS IS AN ISOLATED INCIDENT. THE PRODUCT 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, SUGGEST THAT THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. HOWEVER, THERE IS NO EVIDENCE OF ADDITIONAL NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THIS FAILURE WAS MANUFACTURING AND QUALITY CONTROL DEFICIENCY. 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 BY A DISTRIBUTOR, UPON RECEIVING AND INSPECTING A MICROPUNCTURE TRANSITION LESS ACCESS SET, IT WAS NOTED THAT THE STERILE PACKAGING WAS NOT SEALED. BECAUSE THIS WAS FOUND WITHIN A DISTRIBUTION FACILITY, THERE WAS NO IMPACT TO ANY PATIENT OR END USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1347318 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G47942 16145305 00827002479425

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown