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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

It was reported that a patient was scheduled for a chemotherapeutic embolization procedure and in preparation for the procedure the physician was testing the integrity of the device.The physician noted the device was leaking.This was noticed before the procedure.The device did not make patient contact, there was no patient injury and the patient did not require any additional procedures as a result of this report.

Manufacturer Narrative

A review of the complaint history, drawings, device history record, trends, manufacturing instructions, quality control, and visual inspection / functional testing of the returned device was conducted during the investigation.One used three-way plastic stopcock was returned for investigation.Two cracks were noted at the base of the stopcock.Crack 1 is 4mm in length, and crack 2 is 2mm in length.Stopcock leaked during leak test.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There was one other reported complaint for this lot number, also for leakage.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Measures have been conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

Event Description

It was reported that a patient was scheduled for a chemotherapeutic embolization procedure and in preparation for the procedure the physician was testing the integrity of the device.The physician noted the device was leaking.This was noticed before the procedure.The device did not make patient contact, there was no patient injury and the patient did not require any additional procedures as a result of this report.The physician pulled another stopcock to complete the procedure without incident.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6494230
• MDR Text Key: 72842411
• Report Number: 1820334-2017-00801
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)181101(10)4637767
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2017

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 Model Number: N/A
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2017
• Initial Date FDA Received: 04/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1