MAUDE Adverse Event Report: COOK INC PIVET GUIDE EMBRYO TRANSFER SET; MQF CATHETER, ASSISTED REPRODUCTION

Model Number	G30457
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510 (k) #: 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.
Event or Problem Description
As reported, during an embryo transfer procedure, foreign matter was found inside the inner catheter of a pivet guide embryo transfer set when preparing to load the device with embryos under a microscope.Cook blastocyst culture solution and another manufacturer's syringe were used during the procedure.The procedure was completed using another new device.No adverse effect to the patient was reported.
Additional Manufacturer Narrative
Correction: this report is being sent to indicate the complaint event is not reportable under fda 21 cfr part 803.As such, this event no longer meets the set criteria for a reportable event; no further reports regarding this event will be submitted.The initial report was submitted based on the report of possible foreign matter found inside the catheter of a pivet guide embryo transfer set when preparing to load the device with embryos under a microscope.Additional information was received 09feb2023 advising there was no foreign matter visible inside the product prior to fluid entering the device.The bubbles they saw in the transfer catheter were in the aspirated media and not in the device material.There was not a report of foreign matter after all.Event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death or serious injury and additional information was received advising there was no foreign matter in the device.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.
Event or Problem Description
Additional information was received on 09feb2023: there was no foreign matter visible inside the device prior to fluid entering the device.The bubbles noted in the aspirated media and not on the device surface.

• Brand Name: PIVET GUIDE EMBRYO TRANSFER SET
• Common Device Name: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15934098
• Report Number: 1820334-2022-01819
• Device Sequence Number: 12395882
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)240324(10)13843622
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2024
• Device Model Number: G30457
• Device Catalogue Number: K-PETS-5000
• Device Lot Number: 13843622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/14/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BD SYRINGE
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 60 KG