MAUDE Adverse Event Report: COOK INC THREE-WAY PLASTIC STOPCOCK; KGZ ACCESSORIES, CATHETER

Catalog Number PTWS-2FLL-MLL-R

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number = exempt.(b)(4).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.

Event Description

It was reported, a leak was noted in three, three-way plastic stopcocks from two different lots during the same patient procedure.A transarterial chemoembolization (tace) procedure was being performed.The physician was attempting to mix an anticancer drug and contrast medium by utilizing the three-way plastic stopcock, when leakage through a crack in the stopcock was confirmed (reference medwatch 1820334-2018-02121).Two additional three-way plastic stopcocks from the same lot were then utilized and both presented with cracks and leakage, as well (reference medwatch 1820334-2018-02120).Subsequently, the physician successfully completed the procedure without using a three-way plastic stopcock.The patient did not experience any adverse effect due to this occurrence.Per the complainant, the used devices will not be returned to the manufacturer for investigation, as they were discarded at the user facility.After the event, multiple unopened three-way plastic stopcock packages from the same lot as the two consecutive devices used were opened for inspection.Cracks were noted by the customer in these devices as well (this report).These were not used in any procedure and will be returned for investigation.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.A review of the complaint history, device history record, documentation, drawing, manufacturing instructions, quality control, and a visual inspection and functional evaluation of the returned unused devices were conducted during the investigation.The devices matched the lot number of the complaint device.The actual complaint device was not returned for evaluation.The visual inspection of the returned representative devices confirmed the presence of cracks in the bodies of all the devices.All devices proceeded to leak when tested.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the information provided, the examination of the returned representative products, and the results of our investigation, the root cause was determined to be related to the manufacturing processes of the devices.Measures are being conducted to address this failure mode.We 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.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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.Refer to section h10 for investigation findings.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7706303
• MDR Text Key: 114579869
• Report Number: 1820334-2018-02268
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)200521(10)5900079
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2020
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 5900079
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1