BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 7143874 · Received December 22, 2017

    Report

    Report Number
    1820334-2017-04339
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    November 30, 2017
    Report Date
    April 19, 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 · 1

    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. SEVEN (7) DEVICES WERE RETURNED FOR INVESTIGATION. THE GUIDE CATHETERS WERE RETURNED UNOPENED. A VISUAL EXAMINATION NOTED AN UNKNOWN SUBSTANCE CAN BE SEEN ON THE INSIDE OF THE TRANSFER CATHETERS. 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 1820334-2017-04428. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 FOREIGN USER FACILITY REPORTED THAT PRIOR TO USE THEY NOTICED AN OILY LIQUID IN THE PIVET GUIDE EMBRYO TRANSFER CATHETER. 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
    922644 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1