BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOFT-TRANS EMBRYO TRANSFER CATHETER

    MDR report key: 6785574 · Received August 10, 2017

    Report

    Report Number
    1820334-2017-02298
    Event Type
    Malfunction
    Date Received
    August 10, 2017
    Date of Event
    August 3, 2017
    Report Date
    November 9, 2017
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002266698
    PMA / PMN Number
    K983594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION ¿ EVALUATION: TWO TRANSFER CATHETERS, ONE GUIDE CATHETER AND ONE OBTURATOR WAS RETURNED FOR INVESTIGATION. ALSO RETURNED WAS ONE BOTTLE WITH MEDIA LABELED AS G-IVF PLUS, LOT NUMBER 506677, EXPIRATION 11-30-2017, AND MANUFACTURED BY BITROLIFE. A VISUAL EXAMINATION OF THE RETURNED MEDIA NOTED UNIDENTIFIED FOREIGN MATTER IN THE BOTTLE. THE TRANSFER CATHETER WAS CHECKED AND THE CANNULA AND TUBING LOOKS CLEAN. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE DEVICE HISTORY RECORD FOR THE PRODUCT/LOT WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES DURING THE MANUFACTURING PROCESS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS REPORTED ISSUE. A REVIEW OF COMPLAINT HISTORY REVEALED THERE HAVE BEEN ONE OTHER COMPLAINT ASSOCIATED WITH THIS COMPLAINT LOT NUMBER 7939954. THE OTHER COMPLAINT WAS RECEIVED FROM THE SAME CUSTOMER. A REVIEW OF THE COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, DOCUMENTATION, QUALITY CONTROL, AND A PHYSICAL INSPECTION/ANALYSIS OF THE RETURNED DEVICES WAS CONDUCTED AND NO ISSUES WERE FOUND WITH THE SOFT-TRANS EMBRYO TRANSFER CATHETER. THE DEFINITIVE ROOT CAUSE OF THIS DEVICE ISSUE COULD NOT BE DETERMINED AND NO CONCLUSION CAN BE DRAWN. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED PRIOR TO ALL EMBRYO TRANSFERS THE CATHETERS ARE FLUSHED USING CLEAR VITROLIFE MEDIA. DURING THE LAST EMBRYO TRANSFER OF THE DAY, THE SOFT-TRANS EMBRYO TRANSFER CATHETER WAS FLUSHED WITH MEDIA BUT THE FLUID CAME OUT YELLOW. THE CATHETER WAS NOT USED. ALL REMAINING MEDIA FROM THE SAME LOT WAS CHECKED AND NO SIGN OF DISCOLORATION WAS FOUND. A NEW CATHETER WAS FLUSHED WITH A FRESH TUBE OF MEDIA AND THE LIQUID CAME OUT CLEAR. THE NEW CATHETER WAS USED FOR THE EMBRYO TRANSFER. ACCORDING TO THE REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE YELLOW EXPELLED LIQUID WAS VIEWED UNDER THE MICROSCOPE. NO SIGN OF GROWTH WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565538 SOFT-TRANS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC 00827002266698

    Patients

    Seq Age Sex Outcome Treatment
    1