BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 15934157 · Received December 7, 2022

    Report

    Report Number
    1820334-2022-01820
    Event Type
    Malfunction
    Date Received
    December 7, 2022
    Date of Event
    November 14, 2022
    Report Date
    March 9, 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

    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. THE INITIAL REPORT WAS SUBMITTED BASED ON THE REPORT OF POSSIBLE FOREIGN MATTER FOUND INSIDE THE CATHETER OF A PIVET GUIDE EMBRYO TRANSFER SET WHEN PREPARING TO LOAD THE DEVICE WITH EMBRYOS UNDER A MICROSCOPE. ADDITIONAL INFORMATION WAS RECEIVED ADVISING THERE WAS NO FOREIGN MATTER VISIBLE INSIDE THE PRODUCT PRIOR TO FLUID ENTERING THE DEVICE. THE BUBBLES THEY SAW IN THE TRANSFER CATHETER WERE IN THE ASPIRATED MEDIA AND NOT IN THE DEVICE MATERIAL. THERE WAS NOT A REPORT OF FOREIGN MATTER AFTER ALL. EVENT IS NOT REPORTABLE UNDER FDA 21 CFR PART 803 AS IT DOES NOT MEET THE CRITERIA FOR A DEATH OR SERIOUS INJURY AND ADDITIONAL INFORMATION WAS RECEIVED ADVISING THERE WAS NO FOREIGN MATTER IN THE DEVICE. 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)#: 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

    ADDITIONAL INFORMATION WAS RECEIVED: THERE WAS NO FOREIGN MATTER VISIBLE INSIDE THE DEVICE PRIOR TO FLUID ENTERING THE DEVICE. THE BUBBLES WERE NOTED IN THE ASPIRATED MEDIA AND NOT ON THE DEVICE SURFACE.

    Description of Event or Problem · 0

    AS REPORTED, DURING AN EMBRYO TRANSFER PROCEDURE, FOREIGN MATTER WAS FOUND INSIDE THE INNER CATHETER OF A PIVET GUIDE EMBRYO TRANSFER SET WHEN PREPARING TO LOAD THE DEVICE WITH EMBRYOS UNDER A MICROSCOPE. COOK BLASTOCYST CULTURE SOLUTION AND ANOTHER MANUFACTURER'S SYRINGE WERE USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING ANOTHER NEW DEVICE. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357768 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G30457 13898934 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female BD SYRINGE