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

Model Number N/A

Device Problem Leak/Splash (1354)

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

Event Date 07/13/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported during a chemo-embolization procedure, 7 different three-way plastic stopcocks were used to mix the chemo therapeutic liquid, all 7 of the device were reported to be leaking from the rear of the faucet.The devices were reported to all be from the same lot number.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

(b)(4).Investigation/evaluation: during the course of the investigation, a review of the complaint history, quality control, manufacturing instructions (mi), and trends of the product was conducted.The complaint device was not returned.Therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.It is feasible to suggest the stopcock body was cracked, which allowed leakage.It is not clear at what point the device could have been damaged.Initial analysis suggests that dimensional interference designed to ensure the sealing ability of the valve and prevent bypass may be too excessive.However a definitive root cause cannot be determined.We will continue to monitor for similar complaints and have notified the appropriate internal personnel.Per the quality engineering risk assessment, no further action is required.

Event Description

It was reported during a chemo-embolization procedure, 7 different three-way plastic stopcocks were used to mix the chemo therapeutic liquid, all 7 of the device were reported to be leaking from the rear of the faucet.The devices were reported to all be from the same lot number.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.

• 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: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 5878328
• MDR Text Key: 52189453
• Report Number: 1820334-2016-00801
• Device Sequence Number: 1
• Product Code: KGZ
• UDI-Device Identifier: 00827002002197
• UDI-Public: (01)00827002002197(17)200313(10)5718281
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

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: PTWS-2FLL-MLL-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/18/2016
• Date Device Manufactured: 03/13/2015
• 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