BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER

    MDR report key: 19822069 · Received July 24, 2024

    Report

    Report Number
    1820334-2024-01002
    Event Type
    Malfunction
    Date Received
    July 24, 2024
    Date of Event
    July 8, 2024
    Report Date
    August 30, 2024
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002347830
    PMA / PMN Number
    K173686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS: D4: MODEL # = GPN #. INVESTIGATION - EVALUATION: IT WAS REPORTED THE GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER'S STERILIZED PACKAGING WAS FOUND CONTAMINATED UPON OPENING, PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), SPECIFICATIONS, AND QUALITY CONTROL (QC) PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICE(S) WAS ALSO CONDUCTED. DEVICE WAS RETURNED FOR INVESTIGATION IN AN OPEN INNER POUCH WITHOUT LABEL. THERE WAS SOME YELLOWING ON THE BACK OF THE POUCH. SINCE THE INNER POUCH WAS OPENED IT CANNOT BE DETERMINED IF THERE WAS FOREIGN MATTER IN THE POUCH. THE DEVICE HAD SOME DAMAGE TO IT INDICATING IT HAD BEEN USED. COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOUND NO RELATED NON-CONFORMANCES REPORTED FOR LOT. A COMPLAINT HISTORY DATABASE SEARCH SHOWED NO OTHER RELATED COMPLAINTS ASSOCIATED WITH THE FAILURE MODE FOR THE COMPLAINT DEVICE LOT. BECAUSE THERE ARE NO RELATED NON-CONFORMANCES, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT RELATED COMPLAINTS THAT HAVE BEEN RECEIVED FROM THE FIELD, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU SUPPLIED WITH THE DEVICE DID NOT PROVIDE ANY INFORMATION RELATED TO THE REPORTED ISSUE. THE PACKAGING POUCHES ARE 100% INSPECTED FOR DEFECTS PRIOR TO DISTRIBUTION. THERE WERE NO RELATED NONCONFORMANCES OR COMPLAINTS ASSOCIATED WITH THE COMPLAINT LOT NUMBER. BASED UPON THE AVAILABLE INFORMATION AND RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED, IT IS MOST LIKELY THE FOREIGN MATTER ON THE PACKAGING OCCURRED DURING SHIPMENT OR STORAGE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THE GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER'S STERILIZED PACKAGING WAS FOUND CONTAMINATED UPON OPENING, PRIOR TO AN UNSPECIFIED PROCEDURE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER SAME-LIKE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE DEVICE DID NOT MAKE PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358272 GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G34783 15678286 00827002347830

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown