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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.

Event Description

It was reported the facility had "3 different instances" with stopcocks that were leaking, reportedly "no patient outcomes were compromised." no additional information was available at the time of this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation: a review of the complaint history, drawings, device history record, manufacturing instructions, quality control, and visual inspection / functional testing of unused product was conducted during the investigation.Eight unused sealed three-way stopcocks were returned for evaluation.The devices were visually examined for defects and tested for leaks.No visible cracks or device leakage were noted.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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 and results of the investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.Investigation - evaluation: a review of the complaint history, drawings, device history record, manufacturing instructions, quality control, and visual inspection / functional testing of unused product was conducted during the investigation.Eight unused sealed three-way stopcocks were returned for evaluation.The devices were visually examined for defects and tested for leaks.No visible cracks or device leakage were noted.A document-based investigation evaluation was also performed.There is no evidence to suggest the product was not made to specifications.Review of device history record shows 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 and results of the investigation, a definitive root cause could not be determined.Measures have been previously conducted to address this failure mode.We will continue to monitor for similar complaints.

Event Description

It was reported that the three-way stopcock leaked when connected to the shuttle sheath with a y-adapter.The device was replaced with a new one.No further information was provided.

• Brand Name: THREE-WAY PLASTIC ROTATING ADAPTER 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: 6170755
• MDR Text Key: 62378249
• Report Number: 1820334-2016-01535
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002012035
• UDI-Public: (01)00827002012035(17)210602(10)7017796
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2017

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: 1PTWS-RA-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/13/2016
• Supplement Dates Manufacturer Received: 06/22/2017
• Supplement Dates FDA Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2016
• 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