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

Catalog Number PTWS-2FLL-MLL-R

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) number: exempt.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, during a chemoembolization procedure, chemotherapy drugs were being injected when it was immediately noted the bottom portion of two three-way plastic stopcock devices were leaking.There was no blood loss because the leak was noticed prior to connecting to the patient.The procedure was completed using a another manufacturer's device with a 10ml syringe.The patient's outcome was described as good.The patient did not experience any adverse effects as a result of this occurrence.According to the customer, the complaint device will not be returned to the manufacturer to aid in the investigation.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation/evaluation: reviews of the complaint history, device history record, quality control, and a visual inspection of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a photo of the device label was provided, reviewed, and found to be without error.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 shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, reviews of the manufactures instructions and quality control procedures were conducted, and a gap was discovered.Per our quality control procedures, the products tested on high pressure must be discarded.However, the work order does not notate or list that those devices from the lot were in fact checked or discarded.Measures are being conducted to address this issue.Moreover, a business objects report was run to determine how often this failure mode has occurred over the past three years.The occurrence rate was determined to be within the current range captured by the risk documentation associated with this device failure.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be established.Measures are being conducted to address this failure mode.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.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5 - the two three-way plastic stopcocks leaked in separate procedures.Please reference medwatch 1820334-2019-00605 for event 2 of 2.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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 Description

Please see h10.

• 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: 8394994
• MDR Text Key: 138420540
• Report Number: 1820334-2019-00433
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)220410(10)7815692
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 7815692
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 03/07/2019; 03/27/2019
• Supplement Dates FDA Received: 03/07/2019; 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1