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

Model Number	N/A
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	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- customer (person): phone: (b)(6); postal code: (b)(6).E3- occupation: agent.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 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 or that a death or serious injury occurred; nor is it admission 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
It was reported that impurities were observed on the inner wall of the transfer catheter from a pivet guide embryo transfer set.Prior to use, the outer packaging of the product was inspected and found to have no obvious problems or damage.While preparing to absorb the embryo, impurities were discovered on the inner wall of the transfer catheter under microscopic examination.This occurred with a total of three different catheters.The fourth catheter was used to successfully complete the transfer procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
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
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary it was reported that impurities were observed on the inner wall of the transfer catheter from a pivet guide embryo transfer set.Prior to use, the outer packaging of the product was inspected and found to have no obvious problems or damage.While preparing to absorb the embryo, impurities were discovered on the inner wall of the transfer catheter under microscopic examination.This occurred with a total of three different catheters.The fourth catheter was used to successfully complete the transfer procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Investigation ¿ evaluation reviews of the complaint history, device history record (dhr), manufacturing instructions (mi), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Three devices were returned to cook in open packaging.All three transfer catheters had what appears to be dried media in tubing.No other problems noted.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 dhr for the reported complaint device lot revealed two recorded non-conformances relevant to the failure mode.One was for ¿surface defects¿ in which 48 devices were scrapped and the other was for ¿device discoloration¿ in which two devices were scrapped.A database search identified seven other complaints reported for an unrelated failure mode.There were no complaints related to material impurities noted before aspiration.Current controls are in place to inspect the device for material surface imperfections, discolorations, flaws, etc.Related nonconformances were identified and scrapped prior to distribution.Review of the work order revealed passing mouse embryo assay (mea) prior to distribution.Based on the information collected during the investigation, cook has concluded that there is no evidence suggesting the product was manufactured out of specification or that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The product ifu, ¿embryo transfer catheter¿ does not provide any information to the user related to the reported failure mode.Based on the information provided, inspection of the returned device, and the results of the investigation, a definitive cause of the impurities could not be determined.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per 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.

• 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: 17501941
• Report Number: 1820334-2023-01064
• Device Sequence Number: 2332192
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)251010(10)15003678
• 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): 11/20/2023

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: 10/10/2025
• Device Model Number: N/A
• Device Catalogue Number: K-PETS-5000
• Device Lot Number: 15003678
• 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: 08/04/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 11/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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 Age: 45 YR
• Patient Sex: Female
• Patient Weight: 61 KG