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

Model Number	G30457
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during an in vitro fertilisation, embryo transfer procedure, it was found that the inner wall of the unused new packaged pivet guide embryo transfer set, had visible dirt on it, and the catheter was suspected of being contaminated.The catheter was not used and replaced with a brand-new catheter.The device did not make patient contact.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.G4: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.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Corrected information: e4 - in our initial mdr report we indicated that the initial reporter also sent report to fda.It is unknown if the initial reporter also sent report to the fda and this field should have been left blank.Investigation evaluation- description of event: as reported, during an in vitro fertilization - embryo transfer procedure, it was found that the inner wall of the unused new packaged pivet guide embryo transfer set, had visible dirt on it, and the catheter was suspected of being contaminated.The catheter was not used and replaced with a brand-new catheter.The device did not make patient contact.The patient did not require any additional procedures or experience any adverse effects due to this event.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturing instructions (mi), and quality control (qc) procedures, were conducted during the investigation.The product was not available to return for examination.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) was performed and related nonconformance's were identified and scrapped prior to distribution.A review of complaint history records shows there were no other complaints associated with the complaint lot number.Review of the work order revealed passing mouse embryo assay (mea) prior to distribution.The information provided upon review of complaint file, device history record, complaint history, and quality control documents did not provide evidence to support that the device was manufactured out of specification or to suggest items in the lot or similar devices in the field or in house are nonconforming cook also reviewed product labeling.The product ifu, does not provide any information to the user related to the reported failure mode.Cook has concluded that the cause for the complaint could not be established.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.

• 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: 20325516
• Report Number: 1820334-2024-01279
• Device Sequence Number: 20809164
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)270201(10)15878859
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2024

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 Model Number: G30457
• Device Catalogue Number: K-PETS-5000
• Device Lot Number: 15878859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 12/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2024
• 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
• Patient Sex: Unknown