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

Catalog Number	K-PETS-5000
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 was reported two pivot guide embryo transfer sets were opened and oily liquid was found on the inner catheter.After flushing the set, the user found the oily liquid was absorbing into the inner wall of the inner catheter.The distributor in china is returning fifty same lot devices.There were no adverse consequences to the patient as a result of this reported issue.The device did not make contact with the patient.
Additional Manufacturer Narrative
Investigation ¿ evaluation: visual inspection of the returned products was conducted.A review of complaint history, the device history record, manufacturing instructions, and specifications has also been performed.Two opened devices and 50 unopened devices were returned for investigation.A visual examination of the opened devices noted foreign matter inside the transfer catheters.Two of the unopened devices were opened for observation.A visual examination of the unopened devices noted no foreign matter.The device history record was reviewed and noted no related non-conformances for the reported failure.A review of complaint history revealed this is the only one complaint associated with complaint lot number 8160706.Fourier transform infrared spectroscopy (ftir) analysis has found the substance to likely be the silicone based medical fluid used for lubrication during the manufacturing tipping process.This testing suggests that a production related issue is likely to be the cause of this failure event.The silicone lubricant used in production has been mouse embryo assay (mea) tested to ensure safety.There is no reason to suspect that the remaining lubrication on the device would have presented a risk for embryo loss if the device had been used.Based on the information available the cause of this issue is manufacturing related.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• 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: 7374118
• Report Number: 1820334-2018-00800
• Device Sequence Number: 13880749
• Product Code: MQF
• UDI-Device Identifier: 00827002304574
• UDI-Public: (01)00827002304574(17)200905(10)8160706
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K983594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2018

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 Catalogue Number: K-PETS-5000
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 06/01/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 06/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1