BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUARDIA ACCESS EMBRYO TRANSFER CATHETER

    MDR report key: 11857860 · Received May 20, 2021

    Report

    Report Number
    1820334-2021-01375
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 7, 2021
    Report Date
    September 2, 2021
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002347830
    PMA / PMN Number
    K173686
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. EVENT DESCRIPTION: AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE THE PRIMARY PACKAGING OF A GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER WAS FOUND UNSEALED. ANOTHER NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED. INVESTIGATION ¿ EVALUATION A VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED. A DOCUMENT BASED INVESTIGATION WAS ALSO PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS, THE INSTRUCTIONS FOR USE, AND QUALITY CONTROL DATA. ONE GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER WAS RETURNED FOR INVESTIGATION. INSPECTION OF THE RETURNED DEVICE NOTED: THE DEVICE WAS RETURNED IN AN OPENED OUTER PACKAGE. THE TRANSFER CATHETER WAS RETURNED IN AN OPENED INNER POUCH. THE POLY WAS REMOVED FROM THE TYVEK TO CHECK THE SEALS. ALL EDGES OF THE INNER POUCHES HAD COMPLETE SEALS. THE OUTER PACKAGES HAD COMPLETE SEALS ON THE EDGES. THE WIDTH OF THE END SEAL OF THE OUTER POUCH MEASURED 1.2 CM. THE WIDTH OF THE END SEAL OF THE INNER POUCH MEASURED 1 CM. THE SEALS ON THE PACKAGES AND POUCHES WERE COMPLETE AND SOLID. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED FAILURE MODE. A REVIEW OF COMPLAINT HISTORY RECORDS SHOWS NO OTHER COMPLAINTS ASSOCIATED WITH THE COMPLAINT DEVICE LOT. THE INSTRUCTIONS FOR USE (IFU), PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: CAUTION: STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE IF PACKAGE IS BROKEN. THE COMPLAINT DEVICE WAS RETURNED IN AN OPENED OUTER PACKAGE. VISUAL EXAMINATION OF THE RETURNED COMPLAINT PRODUCT REVEALED THE SEALS WERE PRESENT ALONG ALL ENDS OF THE PACKAGING AND THE POUCHES ARE COMPLETE, SOLID, AND THE WIDTH WAS WITHIN SPECIFICATION. ALL PACKAGES ARE INSPECTED FOR PROPER SEAL FORMATION PRIOR TO DISTRIBUTION. AS THE CUSTOMER REPORTED THE SEAL WAS MISSING ENTIRELY, AND THE PRESENCE OF SEALS WERE CONFIRMED THROUGH PHYSICAL EVALUATION OF THE COMPLAINT PRODUCT, THE COMPLAINT WAS NOT CONFIRMED. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED, AND IT WAS DETERMINED THAT NO ADDITIONAL RISK MITIGATING ACTIVITY IS REQUIRED. WE WILL CONTINUE TO MONITOR 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.

    Description of Event or Problem · 0

    THERE IS NO NEW PATIENT OR EVENT INFORMATION TO REPORT.

    Additional Manufacturer Narrative · 1

    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

    AS REPORTED, PRIOR TO AN UNKNOWN PROCEDURE THE PACKAGING OF A GUARDIA¿ ACCESS EMBRYO TRANSFER CATHETER WAS FOUND UNSEALED. ANOTHER NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755867 GUARDIA ACCESS EMBRYO TRANSFER CATHETER MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G34783 13091935 00827002347830

    Patients

    Seq Age Sex Outcome Treatment
    1