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

Catalog Number	PTWS-2FLL-UCC-R
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This report includes information known at this time. a follow-up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that upon inspection in the hospital storage area (prior to use/ opening packaging,) two three-way plastic stopcocks were observed to be cracked.One of the packages was opened to further observe cracking of the device.The devices did not come into contact with the patient.Another three-way plastic stopcock was utilized to successfully complete the procedure.
Additional Manufacturer Narrative
Investigation evaluation: a review of the device history record, manufacturing instructions, quality control, specifications, and a visual inspection of the returned devices were conducted during the investigation.The visual inspection of the returned devices confirmed the presence of cracks at their bases.Additionally, a document based investigation evaluation was 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 products, and the results of our investigation, it was determined that the material used to manufacture this device was cracking due to moisture.Measures are being conducted to address this failure mode.We will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: THREE-WAY PLASTIC STOPCOCK
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7237290
• Report Number: 1820334-2018-00298
• Device Sequence Number: 1176683
• Product Code: KGZ
• UDI-Device Identifier: 00827002002203
• UDI-Public: (01)00827002002203(17)200526(10)5907786
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2018

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
• Operator of Device: Health Professional
• Device Catalogue Number: PTWS-2FLL-UCC-R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/30/2018
• Supplement Date Received by Manufacturer: 05/02/2018
• Initial Report FDA Received Date: 02/02/2018
• Supplement Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1