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 Patient Involvement (2645)

Event Date 03/18/2019

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, prior to patient contact, the physician mixed contrast medium for an unknown procedure but, the three-way plastic stopcock was "broken".Three additional three-way plastic stopcocks were attempted for use but they were all "broken".All four devices were from the same lot.The physician changed to a metal stop cock which was used to complete the procedure.No patient adverse effects have been reported as a result of this occurrence.Follow up information was provided indicating the devices leaked.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, or unavailable.Investigation - evaluation a review of the complaint history, drawings, dimensional verification, device history record, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.The visual inspection of the returned device confirmed that the stopcocks leaked under the stem on the hex nut side of the stopcock body.Additionally, cracks were noted in this area on all of the devices.This device is not provided with instructions for use and product labeling does not address the reported failure.A document based investigation evaluation was also 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 product, and the results of our investigation, it has been concluded that this failure is related to the design of the device.Appropriate measures have been initiated to address this failure mode.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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

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

• 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: 8458729
• MDR Text Key: 140165174
• Report Number: 1820334-2019-00702
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)210324(10)6838659
• 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
• Report Date: 05/02/2019

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: 03/24/2021
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Device Lot Number: 6838659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Initial Date Manufacturer Received: 03/18/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 04/23/2019
• Supplement Dates FDA Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1