BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 20158019 · Received September 6, 2024

    Report

    Report Number
    1820334-2024-01189
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 28, 2024
    Report Date
    March 26, 2025
    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

    E1: (B)(6). G4 ¿ 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. 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

    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. H6 ANNEX CODE A: A1409. INVESTIGATION HAS DETERMINED THE ALLEGED MALFUNCTION CORRESPONDS WITH LUMEN OCCLUSION. THE CATHETER LUMEN WAS OCCLUDED INSTEAD OF FOREIGN MATTER, WHICH OUR INITIAL REPORT WAS BASED ON. INSPECTION OF THE RETURNED DEVICE FOUND THERE WAS EXCESS DEVICE MATERIAL ON THE TRANSFER CATHETER TIP. THE EXCESS MATERIAL IS MOST LIKELY THE RESULT OF THE TIPPING PROCESS. 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 A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED, UPON OPENING THE PIVET GUIDE EMBRYO TRANSFER SET'S PACKAGE A FOREIGN OBJECT WAS FOUND AT THE FRONT END OF THE INNER TUBE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073195 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G30457 15565415 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female