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

Catalog Number	K-JETS-7019-ET
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Occupation: non-healthcare professional.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 that while preparing supplies for an embryo transfer procedure using a k-jets-7019-et, a foreign body was observed in the transfer catheter.It was verified that this was discovered prior to any patient being prepped for the procedure, therefore there was no patient involvement.
Additional Manufacturer Narrative
Investigation evaluation.Six devices were received and a physical examination was performed on each device.A document based investigation was conducted including a review of complaint history, the device history record, instructions for use, quality control data, and specifications.Six opened packages labeled k-jets-7019-et with lot number 8547337 were received for investigation.The inner pouches were returned unopened.Visual examination confirmed fuzz wrapped around the silicone positioner on one guide catheter.The other five devices showed no sign of foreign matter.The device history record was reviewed and noted there were non-conformances identified for foreign material.The appropriate product and quality managers have been notified.A search of complaint records revealed there have been no other complaints associated with lot 8547337.The complaint is confirmed based on inspection of one returned device.This failure mode is a manufacturing related incident.The risk analysis for observed foreign matter failure mode was reviewed.It was determined that no additional risk mitigating activity is required at this time.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.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
There has been no new information received since the last report was submitted.

• Brand Name: GUARDIA ACCESSET EMBRYO TRANSFER CATHETER
• Common Device Name: MQF CATHETER, ASSISTED REPRODUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8164527
• Report Number: 1820334-2018-03686
• Device Sequence Number: 2745369
• Product Code: MQF
• UDI-Device Identifier: 00827002530072
• UDI-Public: (01)00827002530072(17)210215(10)8547337
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K983594
• 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): 01/18/2019

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: 02/15/2021
• Device Catalogue Number: K-JETS-7019-ET
• Device Lot Number: 8547337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 01/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1