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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported during administration of hepatic chemoembolization with a mixture of lipidol (pdc) and adriblastine, a drop of the mixture fell on the table field without contacting the operator.The chemotherapy was not given in full.Reportedly there was no contact with the skin.The retained devices have not been in contact with chemotherapy products.Several attempt have been made for further information to verify if this was prior to use as reported and to verify if the patient received the full chemotherapy treatment.No additional information was available at the time of this report.

Manufacturer Narrative

A review of the complaint history, drawings, device history record, documentation, manufacturing instructions, and visual inspection of the returned devices was performed during the investigation.The visual inspection of two unopened three-way plastic stopcocks was performed.The used, failed device was not returned due to contact with chemotherapy products.A leak test was performed and both devices failed.Also, both devices exhibited a 2mm crack in the base of the device.The device examination for the third device which was received opened is documented under manufacturer report number 1820334-2016-01342.A document based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows no nonconforming events which could contribute to this failure mode.It should be noted this is one of two reported complaints for this lot number from the same customer.Based on the information provided and the results of our investigation, there is not enough evidence to confirm a definitive root cause for the reported event.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.

• 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: 6116168
• MDR Text Key: 60415943
• Report Number: 1820334-2016-01348
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)190401(10)4933228
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

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?: Yes
• Initial Date Manufacturer Received: 10/26/2016
• Initial Date FDA Received: 11/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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