BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIVET GUIDE EMBRYO TRANSFER SET

    MDR report key: 16639607 · Received March 29, 2023

    Report

    Report Number
    1820334-2023-00341
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    March 8, 2023
    Report Date
    June 23, 2023
    Manufacturer
    COOK INC
    Product Code
    MQF
    UDI-DI
    00827002304574
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER ADDRESS = (B)(6). CUSTOMER OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = 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 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, UNAVAILABLE, OR UNCHANGED. EVENT SUMMARY: IT WAS REPORTED THAT A PIVET GUIDE EMBRYO TRANSFER SET HAD IMPURITIES FOUND AT THE TIP OF THE INNER TUBE UNDER A MICROSCOPE. THIS WAS DISCOVERED AFTER THE EMBRYO WAS ABSORBED FROM THE PETRI DISH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION ¿ EVALUATION: A DOCUMENT BASED INVESTIGATION WAS PERFORMED INCLUDING A REVIEW OF COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL PROCEDURES, AS WELL AS, A VISUAL INSPECTION OF THE DEVICE WERE CONDUCTED. THE DEVICE WAS RETURNED TO COOK IN AN OPEN PACKAGE FOR INVESTIGATION. BLACK SPECS WERE NOTED IN THE TRANSFER CATHETER. IT WAS UNABLE TO BE DETERMINED IF IN MATERIAL OR INSIDE THE CATHETER. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. ONE RELATED NON-CONFORMANCE WAS RECORDED FOR SURFACE DEFECTS. NONCONFORMANCES RELATED TO SURFACE DEFECTS WERE IDENTIFIED AND SCRAPPED PRIOR TO DISTRIBUTION. THE REMAINING NONCONFORMANCES WERE DETERMINED TO BE UNRELATED TO THE COMPLAINT FAILURE MODE. NO ADDITIONAL COMPLAINTS WERE RECEIVED FOR THIS PRODUCT LOT. THE DEVICE HISTORY RECORD REVIEW PROVIDES OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. WO REVIEW REVEALED THE LOT NUMBER HAD PASSING MEA AND LAL TESTING RESULTS. A REVIEW OF RELEVANT MANUFACTURING DOCUMENTS WAS CONDUCTED. SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE DEVICE IS PROVIDED WITH INSTRUCTIONS FOR USE WHICH STATE: "NOTE: ONE CELL MEA TESTED AND PASSED WITH 80% OR GREATER BLASTOCYST DEVELOPMENT WITHIN 96 HRS. USP ENDOTOXIN (LAL) TESTED AND PASSED WITH 20 EU OR LESS PER DEVICE. HOW SUPPLIED: SUPPLIED STERILIZED BY ETHYLENE OXIDE GAS IN PEEL-OPEN PACKAGES. INTENDED FOR ONE-TIME USE. STERILE IF PACKAGE IS UNOPENED AND UNDAMAGED. DO NOT USE THE PRODUCT IF THERE IS DOUBT AS TO WHETHER THE PRODUCT IS STERILE. STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM THE PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED A DEFINITIVE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. SINCE THE DEVICE WAS RETURNED IN POTENTIALLY USED CONDITION, IT IS POSSIBLE THE MARK NOTED ON THE MATERIAL COULD BE DRIED CULTURE MEDIA THAT COULD NOT BE WASHED AWAY. COOK WILL CONTINUE MONITORING OF SIMILAR COMPLAINTS AND HAS NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER A REVIEW OF RISK DOCUMENTATION, 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

    IT WAS REPORTED THAT A PIVET GUIDE EMBRYO TRANSFER SET HAD IMPURITIES FOUND AT THE TIP OF THE INNER TUBE UNDER A MICROSCOPE. THIS WAS DISCOVERED AFTER THE EMBRYO WAS ABSORBED FROM THE PETRI DISH. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTION DUE TO THIS OCCURRENCE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED BUT IS NOT AVAILABLE AT THIS TIME.

    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
    210741 PIVET GUIDE EMBRYO TRANSFER SET MQF CATHETER, ASSISTED REPRODUCTION MQF COOK INC G30457 14601553 00827002304574

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown