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 device has been requested and not yet received.The event is currently under investigation.

Event Description

It was reported, during an unspecified procedure, the three-way plastic stopcock leaked during the mix of lipidol / chemotherapy.There was a reported product mix loss of 4cc.The doctor had to make a 2nd attempt.An associated report, #1820334-2017-00325.

Manufacturer Narrative

Investigation - evaluation.A review of the drawings, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, and quality control was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A review of the non-conformance data, revealed one non-conformance for the complaint lot number.A complaint history review revealed this is the only complaint for this lot number.Based on the information provided and the results of our investigation, the root cause was determined to be design-related.Measures have been initiated to address this issue.We will notify the appropriate personnel and 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: 6383451
• MDR Text Key: 69269870
• Report Number: 1820334-2017-00326
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)190701(10)5111430
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/07/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 08/09/2017
• Date Device Manufactured: 07/01/2014
• 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