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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that prior to patient contact for an unspecified procedure, involving a three-way plastic stopcock, a leak was discovered.Leak was discovered prior to patient contact therefore no section of the device remained inside of the patient's body.The patient did not require any additional procedures due to this occurrence.The occurrence did not cause or contribute to the need for additional procedures.

Manufacturer Narrative

(b)(4).Investigation - evaluation: a review of the complaint history, drawings, device history record, manufacturing instructions and quality control was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.Review of device history record shows no nonconforming events which could contribute to this failure mode.There were four other complaints reported for leaking from 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 initiated to address this issue.Monitoring for similar complaints will continue.

Event Description

It was reported that a leak was identified on the three-way plastic stopcock.There was no patient involvement as the event occurred prior to patient contact.

• Brand Name: THREE-WAY PLASTIC 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 ; 8128294891
• MDR Report Key: 6691301
• MDR Text Key: 79277658
• Report Number: 1820334-2017-01571
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)200507(10)5865574
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2017

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: PTWS-2FLL-MLL-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 07/12/2017
• Supplement Dates FDA Received: 07/23/2017
• Date Device Manufactured: 05/07/2015
• 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