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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	06/22/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Blank fields on this form indicate the information is unknown or unavailable.This event is currently under investigation.
Event or Problem 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.
Additional 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
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 5843864
• Report Number: 1820334-2016-00594
• Device Sequence Number: 16253844
• Product Code: KGZ
• UDI-Device Identifier: 00827002065406
• UDI-Public: (01)00827002065406(17)201207(10)6432623
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PTWSC-2FLL-MLL-R-HP
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 02/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other