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 Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.(b)(6).Pma/510k # k173103.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It is reported prior to an invitro fertilization (ivf) procedure using a pivet guide embryo transfer set, when flushing the device, a small piece of plastic fell out from the inner catheter.This device was not used, and was discarded on site.A second device was used to complete the procedure.There were no adverse effects to the patient as a result of this occurrence.
Additional Manufacturer Narrative
Event summary: it is reported prior to an invitro fertilization (ivf) procedure using a pivet guide embryo transfer set, when flushing the device, a small piece of plastic fell out from the inner catheter.This device was not used and was discarded on site.A second device was used to complete the procedure.There were no adverse effects to the patient as a result of this occurrence.Investigation - evaluation: reviews of the complaint history, device history record, instructions for use, manufacturing instructions, specifications, and quality control procedures of the device were conducted during the investigation.No device was returned for investigation.Accordingly, no physical examinations could be performed.A document-based investigation evaluation was performed.No related non-conformances were recorded, and there have been no other reported complaints for this lot number.There is no evidence of additional nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions, specifications, or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which caution, ¿infection may occur due to bacterial contamination of the device during vaginal manipulation, and result in urinary tract infection (uti), pelvic inflammatory disease (pid), or uterine infection.Recommendations to minimize occurrence include use of only embryo compatible materials, flushing the catheter (and any other accessories used) with sterile, compatible culture media, and closely adhering to sterile techniques.¿ based on the available information, cook has concluded that the foreign material was most likely introduced during the manufacturing process.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.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: PIVET GUIDE EMBRYO TRANSFER SET
• Common Device Name: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10379616
• Report Number: 1820334-2020-01451
• Device Sequence Number: 3580863
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)221219(10)10224532
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: 12/19/2022
• Device Model Number: G30457
• Device Catalogue Number: K-PETS-5000
• Device Lot Number: 10224532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR