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

Catalog Number PTWS-2FLL-MLL-R

Device Problem Leak/Splash (1354)

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

Event Date 10/24/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The event is currently under investigation.A supplemental report will be provided upon conclusion.

Event Description

It was reported that while the three-way plastic stopcock was being used to inject "chemdrug" into the patient, leakage occurred.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.  according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation - evaluation.A review of the complaint history, drawings, dimensional verification, device history record, documentation, manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.Four (4) sealed, unused three-way plastic stopcocks were returned for examination; the stopcock utilized during the procedure was not returned.Device 1: one 2 millimeter (mm) crack and one 3 mm crack were noted at the base.Device 2: two 3 mm cracks noted at the base.Device 3: one 3 mm crack noted at the base.Device 4: one 2 mm crack and one 3 mm crack noted at the base.All four devices leaked during leak testing.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, the root cause for the stopcock crack was determined to be related to manufacturing as hydroscopic properties of the stopcock stem material can result in an increase in diameter, raising the potential for cracking of the stopcock body.Appropriate measures have been initiated to address this failure mode.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and 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: 7011017
• MDR Text Key: 92519351
• Report Number: 1820334-2017-03899
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)200106(10)5557243
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/15/2018

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: No Information
• Device Catalogue Number: PTWS-2FLL-MLL-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2015
• 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