BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER

    MDR report key: 8121255 · Received November 30, 2018

    Report

    Report Number
    1820334-2018-03448
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    November 9, 2018
    Report Date
    January 21, 2019
    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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. ADDITIONAL INFORMATION: INVESTIGATION ¿ EVALUATION. VISUAL INSPECTION OF THE RETURNED PRODUCTS WAS CONDUCTED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL DATA HAS ALSO BEEN PERFORMED. SIX DEVICES RETURNED TO MANUFACTURER FOR INVESTIGATION. THE RETURNED PACKAGING CONFIRMS LOT NUMBER 8993738. A VISUAL EXAMINATION TRANSLUCENT FOREIGN MATTER WITHIN THE TUBING ON ALL RETURNED CATHETERS. REVIEW OF THE DEVICE HISTORY RECORD NOTED NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS COMPLAINT TO BE THE ONLY ONE ASSOCIATED WITH COMPLAINT LOT NUMBER 8993738. TESTING OF EARLIER COMPLAINTS WITH THIS SAME FAILURE MODE SHOWS THAT THE CLEAR SUBSTANCE INSIDE THE TRANSFER CATHETER IS LIKELY TO BE A MANUFACTURING FLUID USED TO ASSIST IN THE TIPPING PROCESS. MOUSE EMBRYO ASSAY (MEA) TESTING HAS SHOWN THAT THE PRESENCE OF THIS MANUFACTURING FLUID DID NOT IMPEDE IN THE GROWTH OF THE 1-CELL MOUSE EMBRYO DEVELOPMENT TO THE BLASTOCYST STAGE. IN THE QUANTITIES, LIKELY TO BE SEEN IN THE TRANSFER CATHETER, THIS LUBRICANT IS CONSIDERED SAFE. THE CAUSE FOR THIS SPECIFIC FAILURE MODE IS A MANUFACTURING ISSUE. BASED ON THE INFORMATION AVAILABLE THE CAUSE OF THIS ISSUE IS MANUFACTURING RELATED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED AT THIS TIME. COOK MEDICAL HAS NOTIFIED THE APPROPRIATE PERSONNEL AND WILL CONTINUE TO MONITOR THIS DEVICE VIA THE COMPLAINTS DATABASE FOR SIMILAR COMPLAINTS. 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.

    Description of Event or Problem · 0

    THERE HAS BEEN NO NEW INFORMATION RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. DEVICE CODE: DEVICE CONTAMINATED DURING MANUFACTURE OR SHIPPING IS NOT LABELED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED, AN OILY SUBSTANCE WAS FOUND ON THE INNER PORTION OF THE CATHETER PRIOR TO USE. ADDITIONAL INFORMATION RECEIVED 30NOV2018. FURTHER EVENT CLARIFICATION WAS PROVIDED. THE OPERATOR CHECKED THE DEVICE AND THE ISSUE WAS DISCOVERED PRIOR TO USE DURING THE PREPARATION STAGE. THE IVF PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961043 GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC 8993738 00827002347830

    Patients

    Seq Age Sex Outcome Treatment
    1