BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 15893033 · Received December 1, 2022

    Report

    Report Number
    1820334-2022-01791
    Event Type
    Malfunction
    Date Received
    December 1, 2022
    Date of Event
    November 3, 2022
    Report Date
    March 1, 2023
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002304574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. CORRECTION: THIS REPORT IS BEING SENT TO INDICATE THE COMPLAINT EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803. AS SUCH, THIS EVENT NO LONGER MEETS THE SET CRITERIA FOR A REPORTABLE EVENT; NO FURTHER REPORTS REGARDING THIS EVENT WILL BE SUBMITTED. INVESTIGATION HAS DETERMINED THE ALLEGED MALFUNCTION CORRESPONDS WITH SURFACE DEFECT INSTEAD OF FOREIGN MATTER, WHICH OUR INITIAL REPORT WAS BASED ON. EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH OR SERIOUS INJURY AND THERE IS NO PRECEDENCE OF THIS MALFUNCTION LEADING TO AN ADVERSE EVENT. 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

    PMA/510(K) NUMBER K173103. 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.

    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.

    Description of Event or Problem · 0

    AS REPORTED, DURING AN IN VITRO FERTILIZATION (IVF) PROCEDURE, A PIVET GUIDE EMBRYO TRANSFER SET CATHETER GENERATED BUBBLES (B)(4) IN THE INNER CATHETER AND "UNEVEN OR BLACK SPOTS" WERE NOTICED PRIOR TO ASPIRATION UNDER A MICROSCOPE IN THE FRONT ONE-THIRD SECTION OF THE CATHETER. A BD SYRINGE AND VITROLIFE BLASTOCYST CULTURE MEDIUM WERE USED. THERE WERE NO ADVERSE EFFECTS REPORTED AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW DEVICE OF THE SAME TYPE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2713307 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G30457 14839531 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown