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 Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 02/16/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The reported device has been received, an evaluation is in progress.

Event Description

It was reported, prior to beginning a transcatheter arterial embolization on a patient, the physician started mixing the relevant medications.The physician attempted to flush the three-way plastic stopcock first, but found the three-way plastic stopcock was leaking from the bottom of device.The physician used a second three-way plastic stopcock but still had the problem of leakage when flushing the device.The third three-way plastic stopcock used did not leak.No additional details have been received.

Manufacturer Narrative

(b)(4).Investigation - evaluation.A review of the complaint history, device history record, manufacturing instructions, quality control , and visual inspection / functional testing of the returned device was conducted during the investigation.The visual inspection of the of the three-way plastic stopcock identified stopcock #1 with two cracks measuring one millimeter (mm) and three mm at the base of the stopcock.Stopcock #2 had two cracks present at the base.Both cracks were three mm in length.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.There was one other reported complaint for this lot number.Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined.Measures are being conducted to address this failure mode.Monitoring will continue to be performed for similar complaints.

• 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 ; 8123392235
• MDR Report Key: 6408997
• MDR Text Key: 70074926
• Report Number: 1820334-2017-00376
• 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: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2017

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 76 YR
• Patient Weight: 75