BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 7143857 · Received December 22, 2017

    Report

    Report Number
    1820334-2017-04428
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 5, 2017
    Report Date
    April 20, 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 WAS PERFORMED ON THE RETURNED PRODUCTS. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL DATA AND SPECIFICATIONS HAS BEEN PERFORMED. ONE (1) OPENED DEVICE AND 116 UNOPENED DEVICES WERE RETURNED FOR INVESTIGATION. A VISUAL EXAMINATION OF THE OPENED DEVICE NOTED AN UNKNOWN SUBSTANCE CAN BE SEEN ON THE INSIDE OF THE TRANSFER CATHETER. THE UNOPENED DEVICES WILL BE RESERVED FOR FURTHER TESTING BY QUALITY ENGINEERING. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS PERFORMED ON A SAMPLE OF THE LIQUID SHOWED THAT IT WAS A MATCH TO THE SILICONE LUBRICANT USED ON THE PRODUCTION FLOOR DURING THE TIPPING PROCESS. THIS ANALYSIS SUGGESTS THAT A PRODUCTION RELATED ISSUE IS THE CAUSE OF THIS FAILURE. 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. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED 0 NON-CONFORMANCES RELATED TO THIS REPORTED ISSUE. REVIEW OF COMPLAINT HISTORY RECORDS SHOWED TWO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FOR THIS ISSUE. THE SIMILAR COMPLAINTS WERE REPORTED IN MFR. REPORT #1820334-2017-04175 AND 1820334-2017-04339. MEASURES HAVE BEEN INITIATED TO ADDRESS THIS FAILURE MODE. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). (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 DISTRIBUTOR REPORTED THE USER FACILITY FOUND UNKNOWN LIQUID OF AN OIL SUBSTANCE IN THE PIVOT GUIDE EMBRYO TRANSFER CATHETER. THIS WAS FOUND PRIOR BEFORE USE. 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
    922469 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1