BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 7374118 · Received March 27, 2018

    Report

    Report Number
    1820334-2018-00800
    Event Type
    Malfunction
    Date Received
    March 27, 2018
    Date of Event
    March 19, 2018
    Report Date
    June 7, 2018
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002304574
    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 INSPECTION OF THE RETURNED PRODUCTS WAS CONDUCTED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, AND SPECIFICATIONS HAS ALSO BEEN PERFORMED. TWO OPENED DEVICES AND 50 UNOPENED DEVICES WERE RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION OF THE OPENED DEVICES NOTED FOREIGN MATTER INSIDE THE TRANSFER CATHETERS. TWO OF THE UNOPENED DEVICES WERE OPENED FOR OBSERVATION. A VISUAL EXAMINATION OF THE UNOPENED DEVICES NOTED NO FOREIGN MATTER. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED NO RELATED NON-CONFORMANCES FOR THE REPORTED FAILURE. A REVIEW OF COMPLAINT HISTORY REVEALED THIS IS THE ONLY ONE COMPLAINT ASSOCIATED WITH COMPLAINT LOT NUMBER 8160706. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS HAS FOUND THE SUBSTANCE TO LIKELY BE THE SILICONE BASED MEDICAL FLUID USED FOR LUBRICATION DURING THE MANUFACTURING TIPPING PROCESS. THIS TESTING SUGGESTS THAT A PRODUCTION RELATED ISSUE IS LIKELY TO BE THE CAUSE OF THIS FAILURE EVENT. THE SILICONE LUBRICANT USED IN PRODUCTION HAS BEEN MOUSE EMBRYO ASSAY (MEA) TESTED TO ENSURE SAFETY. THERE IS NO REASON TO SUSPECT THAT THE REMAINING LUBRICATION ON THE DEVICE WOULD HAVE PRESENTED A RISK FOR EMBRYO LOSS IF THE DEVICE HAD BEEN USED. BASED ON THE INFORMATION AVAILABLE THE CAUSE OF THIS ISSUE IS MANUFACTURING RELATED. 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). 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 REPORTED TWO PIVOT GUIDE EMBRYO TRANSFER SETS WERE OPENED AND OILY LIQUID WAS FOUND ON THE INNER CATHETER. AFTER FLUSHING THE SET, THE USER FOUND THE OILY LIQUID WAS ABSORBING INTO THE INNER WALL OF THE INNER CATHETER. THE DISTRIBUTOR IN CHINA IS RETURNING FIFTY SAME LOT DEVICES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS REPORTED ISSUE. THE DEVICE DID NOT MAKE CONTACT WITH THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218235 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1