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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: KGZ ACCESSORIES, CATHETER
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6170755
• Report Number: 1820334-2016-01535
• Device Sequence Number: 589604
• Product Code: KGZ
• UDI-Device Identifier: 00827002012035
• UDI-Public: (01)00827002012035(17)210602(10)7017796
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 1PTWS-RA-R
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 12/13/2016
• Supplement Report FDA Received Date: 06/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1