BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER

    MDR report key: 7046131 · Received November 20, 2017

    Report

    Report Number
    1820334-2017-04175
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Date of Event
    November 10, 2017
    Report Date
    March 28, 2018
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002347830
    PMA / PMN Number
    K983594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: VISUAL AND FUNCTIONAL TESTING OF THE RETURNED PRODUCT. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND SPECIFICATIONS HAS BEEN PERFORMED. TWO DEVICES WERE RETURNED FOR INVESTIGATION. THE CATHETERS WERE VIEWED USING A SCOPE. WATER MARKS WERE NOTED INSIDE THE CATHETER. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED FOUR UNRELATED NON-CONFORMANCE ISSUES. A REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN NO OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER (8010747). BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY AND DEVICE INTEGRITY PRIOR TO SHIPPING. REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT OBSERVE ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. BASED ON THE PROVIDED INFORMATION A DEFINITIVE ROOT CAUSE CANNOT BE ESTABLISHED AT THIS TIME. HOWEVER, IT IS LIKELY TO HAVE OCCURRED DURING THE MANUFACTURING PROCESS. 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 USE, AN UNKNOWN LIQUID WAS SEEN IN THE GUARDIA ACCESS EMBRYO TRANSFER CATHETER. NO PATIENT INVOLVEMENT. NO ADVERSE EFFECTS OR CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825884 GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC 00827002347830

    Patients

    Seq Age Sex Outcome Treatment
    1