MAUDE Adverse Event Report: COOK INC SYDNEY IVF MICROVOL EMBRYO TRANSFER CATHETER SET; MQF CATHETER, ASSISTED REPRODUCTION

Model Number	G18740
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Date of Event	12/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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
As reported, the inner packaging was found open on five sydney ivf microvol embryo transfer catheter sets prior to use in the same embryo transfer procedure.The device did not make patient contact.Another same type device from a different lot number was used to complete the procedure.
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: as reported, the inner packaging was found open on five sydney ivf microvol embryo transfer catheter sets prior to use in the same embryo transfer procedure.The device did not make patient contact.Another same type device from a different lot number was used to complete the procedure.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, specifications, and quality control procedures and a visual inspection of the device were conducted during the investigation.Five sydney ivf microvol embryo transfer catheter sets were returned in opened outer pouches.Visual exam of the first device noted that the inner transfer catheter pouch had seal marks but was open; the guide catheter inner pouch was open, but the seal was visible.The second device was returned with the distal tip closest to the chevron seal of the outer pouch; the chevron seals of the guide catheter inner pouch and transfer catheter inner pouch were open with visible seals.The three remaining devices were returned with both inner pouches opened and visible seals.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.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the manufacturing instructions, specifications, or quality control procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is included with instructions for use which caution, ¿sterile if the package is unopened or undamaged.Do not use if package is broken.¿ the returned complaint product was returned inside opened outer and inner pouches.There were visible seals on all inner pouches, indicating they were sealed during the packaging process and were cleanly peeled away at a later time.Additionally, these inner pouch seals are packaged inside an outer package that maintains sterility.Based on the available information, cook has concluded that a definitive cause of the complaint could not be determined.Cook will continue 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.

• Brand Name: SYDNEY IVF MICROVOL EMBRYO TRANSFER CATHETER SET
• Common Device Name: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11197392
• Report Number: 1820334-2021-00125
• Device Sequence Number: 10923187
• Product Code: MQF
• UDI-Device Identifier: 00827002187405
• UDI-Public: (01)00827002187405(17)220806(10)9910288
• Combination Product (Y/N): N
• PMA/510(K) Number: K983594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2021

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: 08/06/2022
• Device Model Number: G18740
• Device Catalogue Number: K-JETS-7019-SIVF
• Device Lot Number: 9910288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 05/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1