BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 14711382 · Received June 16, 2022

    Report

    Report Number
    1820334-2022-01072
    Event Type
    Malfunction
    Date Received
    June 16, 2022
    Date of Event
    May 16, 2022
    Report Date
    November 3, 2022
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002304574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PHONE: (B)(6). INITIAL REPORTER OCCUPATION: AGENT. PMA/510K #: K173103. 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.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY: AS REPORTED, THE INNER PACKAGE OF A PIVET GUIDE EMBRYO TRANSFER SET CONTAINED WATER DROPLETS. THE DROPLETS DISAPPEARED AFTER 24 HOURS. THE CUSTOMER SUSPECTED THE STERILE ENVIRONMENT OF THE PRODUCT HAD BEEN DAMAGED. THIS WAS NOTED PRIOR TO USE ON ANY PATIENTS. ALL THREE REPORTED AFFECTED DEVICES DISPLAYED THE SAME ISSUE. NO DAMAGE WAS NOTED ON ANY PACKAGING. THE CUSTOMER REPORTS THE DEVICES ARE STORED AS REQUIRED PER THE IFU. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES AND A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THREE UNOPENED PRODUCTS WERE RETURNED FOR INVESTIGATION. NO WATER DROPLETS OR FOREIGN MATTER OF ANY KIND COULD BE SEEN IN ANY OF THE SEALED PACKAGES. ALL SEALS WERE CHECKED, AND ALL WERE COMPLETE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE RECORDED, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH STATE, "STERILE IF THE PACKAGE IS UNOPENED OR UNDAMAGED. DO NOT USE IF PACKAGE IS BROKEN.¿ THOUGH A DISCUSSION WITH THE INTERNAL STERILITY PERSONNEL REVEALED IT IS POSSIBLE THE MOISTURE NOTED COULD BE A RESULT OF ANY PROCESS CHANGE THAT INTRODUCES MORE WATER/MOISTURE TO THE PRODUCT, THERE WERE NO INSTRUCTION UPDATES NEAR THE MANUFACTURING DATE THAT MAY HAVE ADDED TO ADDITIONAL MOISTURE TO THE PRODUCT. BASED ON THE PACKAGING MATERIAL (TYVEK POUCH), AND CONSIDERING THE TRANSOCEANIC TRANSPORT, COOK HAS CONCLUDED THAT THE MOST PROBABLE CAUSE FOR THIS EVENT IS A POST-STERILIZATION TRANSPORT OR STORAGE EVENT. THE CUSTOMER SHOULD ASSUME A POST-STERILIZATION BREACH AND HANDLE IN ACCORDANCE WITH THEIR PROCEDURE FOR DISPOSITION ON STERILITY-COMPROMISED PRODUCT. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF THE 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.

    Description of Event or Problem · 0

    AS REPORTED, THE INNER PACKAGE OF A PIVET GUIDE EMBRYO TRANSFER SET CONTAINED WATER DROPLETS. THE DROPLETS DISAPPEARED AFTER 24 HOURS. THE CUSTOMER SUSPECTED THE STERILE ENVIRONMENT OF THE PRODUCT HAD BEEN DAMAGED. THIS WAS NOTED PRIOR TO USE ON ANY PATIENTS. ALL THREE REPORTED AFFECTED DEVICES DISPLAYED THE SAME ISSUE. NO DAMAGE WAS NOTED ON ANY PACKAGING. THE CUSTOMER REPORTS THE DEVICES ARE STORED AS REQUIRED PER THE IFU.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2208750 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G30457 14228132 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown