BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER

    MDR report key: 7175188 · Received January 9, 2018

    Report

    Report Number
    1820334-2018-00021
    Event Type
    Malfunction
    Date Received
    January 9, 2018
    Date of Event
    December 18, 2017
    Report Date
    April 24, 2018
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002347830
    PMA / PMN Number
    K983594
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: EVALUATION: A VISUAL INSPECTION OF THE RETURNED PRODUCT WAS PERFORMED. IN ADDITION, A DOCUMENTATION BASED INVESTIGATION WAS PERFORMED WHICH INCLUDED A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, AND SPECIFICATIONS. FIFTEEN (15) UNOPEN PACKAGES LABELED RPN K-JETS-7019, LABEL LOT NUMBER: 7943129 WERE RECEIVED. FOREIGN MATTER OF UNKNOWN ORIGIN WAS CONFIRMED EITHER TRAPPED IN THE SEAL OR LOOSE INSIDE THE PACKAGES. ADDITIONAL PHYSICAL EXAMINATION OF THE PARTICULATE FOUND SHOWS THAT NONE IS DEEMED UNACCEPTABLE AS IT STILL MET PRODUCTION REQUIREMENTS IN PLACE FOR FOREIGN MATTER. THE COMPLAINT IS CONSIDERED CONFIRMED FOR CUSTOMER DISSATISFACTION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NOTED TWO (2) NON-CONFORMING ITEMS DURING PRODUCTION THAT ARE RELATED TO FOREIGN MATTER. FOREIGN MATTER WAS FOUND EMBEDDED IN THE DEVICE MATERIAL OF THE TWO ITEMS. BOTH ITEMS WERE SCRAPPED. A REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN NO OTHER COMPLAINT ASSOCIATED WITH THE COMPLAINT DEVICE LOT NUMBER: (7943129). 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. THE RETURNED PRODUCT, WHILE CONFIRMED TO EXHIBIT THE FAILURE MODE THE COMPLAINT WAS OPENED FOR, STILL MET THE PRODUCTION REQUIREMENTS IN PLACE FOR FOREIGN MATTER. BASED ON THE PROVIDED INFORMATION THE REPORTED FAILURE MODE IS LIKELY TO HAVE OCCURRED DURING MANUFACTURING PROCESS. MEASURES HAVE BEEN INITIATED TO ADDRESS THE REPORTED ISSUE OF FOREIGN MATTER. 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)(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

    IT WAS REPORTED PRIOR TO PATIENT USE, DUST WAS FOUND IN THE GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER PACKAGING. 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
    19120 GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC 00827002347830

    Patients

    Seq Age Sex Outcome Treatment
    1