MAUDE Adverse Event Report: COOK INC GUARDIA ACCESS NANO EMBRYO TRANSFER CATHETER; MQF CATHETER, ASSISTED REPRODUCTION

Model Number	G24216
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1: customer (person) address = (b)(6) district, wuhan city hubei province, china; customer (person) postal code = (b)(6).E3: customer occupation = unknown.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
It was reported that the packaging of the 'guardia access nano embryo transfer catheter' was found to be contaminated during an unspecified procedure.The user of the device found a hair particle inside the sterile packaging and refused to use the product.The procedure was completed by using another transfer catheter.As reported, the patient did not require any additional procedure due to this occurrence.The patient did not experience any adverse effects due to this occurrence.The device did not make patient contact.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d3, d9, g1.Investigation ¿ evaluation.It was reported that the packaging of the 'guardia access nano embryo transfer catheter' was found to be contaminated during an unspecified procedure.The user of the device found a hair particle inside the sterile packaging and refused to use the product.The procedure was completed by using another transfer catheter.As reported, the patient did not require any additional procedure due to this occurrence.The patient did not experience any adverse effects due to this occurrence.The device did not make patient contact.Reviews of the complaint history, device history record (dhr), device master record (dmr), and instructions for use (ifu), were conducted during the investigation.Visual inspection of the returned complaint device was also conducted.One sealed device was returned.A dark hair can be seen inside of the sealed package.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) found no related non-conformances reported for lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Cook also reviewed product labeling.The ifu supplied with the device did not provide any information related to the reported issue.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the device was manufactured out of specification due to a packaging operator error.Complaint awareness training has been completed for the relevant personnel.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: GUARDIA ACCESS NANO EMBRYO TRANSFER CATHETER
• 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: 20902169
• Report Number: 1820334-2024-01631
• Device Sequence Number: 17394537
• Product Code: MQF
• UDI-Device Identifier: 00827002242166
• UDI-Public: (01)00827002242166(17)270103(10)15828572
• Combination Product (Y/N): N
• PMA/510(K) Number: K172051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: G24216
• Device Catalogue Number: K-JETS-551910-S
• Device Lot Number: 15828572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2024
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2024
• 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