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 Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a device leaked during an unknown procedure.The procedure was completed by opening additional stopcocks until one worked.The patient did not experience any additional adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, functional test, drawings, device history record, manufacturing instructions, trends and quality control of the returned device was conducted during the investigation.The visual inspection of the returned device reported one used 1ptws-ra-r stopcock was returned for investigation.Stopcock showed no signs of defects.It was liquid tested and passed.It easily opened and closed.The customer stated two stopcocks leaked.Only one of the two was returned for investigation.The stopcock that was not returned will be confirmed for leaking.The complaint device was returned therefore, an investigation evaluation was 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 the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

Event Description

It was reported that a device leaked during an unknown procedure.The procedure was completed by opening additional stopcocks until one worked.The patient did not experience any additional adverse effects due to this occurrence.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5945563
• MDR Text Key: 54527583
• Report Number: 1820334-2016-00944
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002012035
• UDI-Public: (01)00827002012035(17)210429(10)6926887
• 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: 08/16/2016

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: 08/16/2016
• Initial Date FDA Received: 09/13/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2016
• 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