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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Chemical Exposure (2570)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Blank fields on this form indicate the information is unknown or unavailable.This event is currently under investigation.

Event Description

The devices are not waterproof.The radiologist ends up with the chimio on his hands therefore the patient has less treatment.Per the customer complaint form:"leak of product".The patient did not require any additional procedures due to this occurrence.

Manufacturer Narrative

Investigation- a review of the complaint history, device history record, quality control and visual inspection of the returned devices was conducted.No events related to the reported issue were found during a review of related manufacturing or quality records.Review of the associated device history record did not identify non-conformances that may be related to this reported incident.Approx 19 high pressure three-way stopcock of the reported lot number were returned for inspection; all were sealed and unused.The 19 stopcocks were visually examined and no defects were noted.Each stopcock was liquid tested and all passed.No leakage was observed.The device functioned as expected; there is no evidence to suggest the product was not manufactured to current specifications.The stopcocks utilized during the reported event were not returned for inspection; as a result the root cause is undetermined at this time.The proper personnel have been notified of this complaint, we will continue to monitor for similar issues.

• Brand Name: HIGH PRESSURE THREE-WAY STOPCOCK
• Type of Device: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47402 ; 8003462686
• MDR Report Key: 5843864
• MDR Text Key: 51065218
• Report Number: 1820334-2016-00594
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002065406
• UDI-Public: (01)00827002065406(17)201207(10)6432623
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTWSC-2FLL-MLL-R-HP
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/07/2016
• Initial Date FDA Received: 08/03/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other